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Easing Medical Device Regulatory Oversight: The FDA and Testing Amidst the COVID-19 Pandemic

Published online by Cambridge University Press:  18 August 2021

Katelynn Maxwell
Katelynn Maxwell*
Affiliation:
J.D., Boston University School of Law, 2021; B.A., Political Science and Public Health, Muhlenberg College, 2018
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Abstract

The FDA already subjects most medical devices to much less stringent approval requirements than drugs and biologics, and attempts to speed up rollout during the COVID crisis have been problematic. Agency decisions, including to allow antibody test marketing without emergency use authorization or review, and the back-and-forth guidance on laboratory-developed tests, have met harsh criticism and unreliable results. Though the long-term results of these decisions are unclear, the FDA’s credibility, reliability, and commitment to safety are threatened by even further lessening medical device regulatory oversight during the coronavirus pandemic. The relaxed and fix-it-later approach to many of the FDA’s public health emergency decisions regarding medical devices reflect the ongoing criticisms of medical device regulation in general, specifically the 510(k) process and laboratory developed test regulation, offering a point of reflection towards reform. Adaptive legislation and a risk-based and evidentiary approach to premarket and postmarket review can begin to address these issues both generally and in an emergency context.

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Student notes
Information
American Journal of Law & Medicine , Volume 47 , Issue 2-3 , July 2021 , pp. 291 - 326
Copyright
© 2021 The Author(s)

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Footnotes

†

I would like to thank Professor Fran Miller for not only her excellent advising and steadfast enthusiasm, but also her relevant and timely instruction in the course Food, Drug and Cosmetic Law. I would also like to thank my family and friends for their endless support and encouragement, with special thanks to Julia Ottaviani as my own personal editor throughout this process and law school. Lastly, thank you to the American Journal of Law and Medicine editorial board and staff for their dedicated work.

References

1 Official names include COVID-19 or the coronavirus disease. Naming the Coronavirus Disease (COVID-19) and the Virus that Causes It, World Health Org., https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance/naming-the-coronavirus-disease-(covid-2019)-and-the-virus-that-causes-it [https://perma.cc/USV2-HK8S] (last visited Oct. 20, 2020). Official names for the virus that causes COVID-19 include severe acute respiratory syndrome coronavirus 2 or SARS-CoV-2. Id.

2 COVID-19 Dashboard by the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University (JHU), Johns Hopkins U. Med.: Coronavirus Resource Ctr., https://coronavirus.jhu.edu/map.html [https://perma.cc/6542-PLH3] (last visited Dec. 6, 2020).

3 Id.

4 See, e.g., Kurt Campbell & Rush Doshi, The Coronavirus Could Reshape Global Order: China is Maneuvering for International Leadership as the United States Falters, Foreign Affairs, March 18, 2020, at 1 (examining the effects of the Chinese and American responses to the coronavirus pandemic on foreign affairs); Carlos del Rio et al., Long-term Health Consequences of COVID-19, 324 JAMA 1723, 1723 (2020) (reviewing the potential long-term health consequences of COVID-19); Maria Nicola et al., The Socio-economic Implications of the Coronavirus Pandemic (COVID-19): A Review, 78 Int’l J. Surgery 185, 185 (2020) (summarizing the socio-economic effects of COVID-19 on the world economy).

5 See Food & Drug Admin., Coronavirus (COVID-19) Supply Chain Update (Feb. 27, 2020), https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-supply-chain-update [https://perma.cc/UJ7G-4F5S].

6 See Food & Drug Admin., Coronavirus (COVID-19) and Medical Devices (Apr. 9, 2021), https://www.fda.gov/medical-devices/emergency-situations-medical-devices/coronavirus-covid-19-and-medical-devices [https://perma.cc/PV6H-F7L5].

7 See generally Food & Drug Law Inst., A Practical Guide to FDA’s Food and Drug Law and Regulation (Kenneth R. Piña & Wayne L. Pines, 6th ed. 2017). To be discussed later on, the premarket approval process is easily sidestepped by the 510(k) substantially equivalent pathway. See id. at 13-15.

8 Carl Heneghan & Mathew Thompson, Rethinking Medical Device Regulation, 105 J. Royal Soc’y Med. 186, 186-87 (2012).

9 Learn if a Medical Device Has Been Cleared by FDA for Marketing, U.S. Food & Drug Admin., https://www.fda.gov/medical-devices/consumers-medical-devices/learn-if-medical-device-has-been-cleared-fda-marketing#:~:text=43%25%20of%20medical%20devices%20fall,devices%20fall%20under%20this%20category [https://perma.cc/E4KS-L6YR] (last updated Dec. 29, 2017). Other sources report that this number may be as low as one percent. Daniel B. Kramer, Shuai Xu & Aaron S. Kesselheim, How Does Medical Device Regulation Perform in the United States and the European Union? A Systematic Review, 9 PLoS Med. 1 (2012).

10 See 21 U.S.C. § 360c(i) (2018); 21 C.F.R. § 807.92(a)(3) (2020).

11 For a list of 510(k) exempted Class II devices, see Medical Device Exemptions 510(k) and GMP Requirements, U.S. Food & Drug Admin., https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm [https://perma.cc/PEP6-FFNV] (last updated Oct. 19, 2020).

12 Heneghan & Thompson, supra note 8, at 186-87.

13 Josh Makower et al., FDA Impact on U.S. Medical Technology Innovation: A Survey of Over 200 Medical Technology Companies 24 (2010), http://www.medtecheurope.org/wp-content/uploads/2015/09/01112010_FDA-impact-on-US-medical-technology-innovation_Backgrounder.pdf [https://perma.cc/3ULU-CSF9]. In contrast, industry has a more favorable view of the regulatory landscape for vaccines and relies on the FDA’s regulation to instill public confidence. During the pandemic, vaccine manufacturers have even urged the FDA to not abandon its typical rigor in vaccine review in granting an EUA. The same concern for FDA review of medical devices, particularly serological tests, has not matched.

14 How Global Journalists Investigated Medical Device Safety, Associated Press (Nov. 25, 2018), https://www.ap.org/ap-in-the-news/2018/how-global-journalists-investigated-medical-device-safety [https://perma.cc/H5CL-GRLS].

15 See, e.g., Daniel M. Fox & Diana M. Zuckerman, Regulatory Reticence and Medical Devices, 92 Milbank Q. 151, 151 (2014); Heneghan & Thompson, supra note 8, at 186-87; Madelyn Lauer, FDA Device Regulation, 114 Mo. Med. 283, 286 (2017).

16 See Heneghan & Thompson, supra note 8, at 186-87. For example, a hip replacement implanted in 100,000 patients was recalled just two years after 510(k) substantial equivalence approval because there was a reported 49% failure rate. Lauer, supra note 15, at 286.

17 Sam Baker & Andrew Witherspoon, The Pandemic is Getting Worse Again, AXIOS (Oct. 22, 2020), https://www.axios.com/coronavirus-pandemic-getting-worse-9e2dc6ee-fe03-4f08-9425-12017c6b32cb.html [https://perma.cc/XJE7-BJQD].

18 See Megan L. Ranney et. al., Critical Supply Shortages – The Need for Ventilators and Personal Protective Equipment during the Covid-19 Pandemic, 382 New Eng. J. Med e41, e41 (2020).

19 Alex Azar, Determination that a Public Health Emergency Exists Nationwide as the Result of the 2019 Novel Coronavirus, U.S. Dep’t Health & Human Servs.: Pub. Health Emergency (Jan. 31, 2020), https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx [https://perma.cc/ZDB5-CXYK]. This declaration has been renewed continuously since.

20 Determination of Public Health Emergency, 85 Fed. Reg. 7,316, 7,316 (Feb. 7, 2020); Public Health Service Act § 319, 42 U.S.C. § 247d (2018).

21 Stephen M. Hahn, A Closer Look at the FDA’s Center for Radiological Health’s Unprecedented Efforts in the COVID-19 Response, U.S. Food & Drug Admin. (Sept. 29, 2020), https://www.fda.gov/news-events/fda-voices/closer-look-fdas-center-devices-and-radiological-healths-unprecedented-efforts-covid-19-response#Numbers [https://perma.cc/4AXS-MY43].

22 Marijn Janssen & Haiko van der Voort, Agile and Adaptive Governance in Crisis Response: Lessons from the COVID-19 Pandemic, 55 Int’l J. Info. Mgmt. 102180, 102180 (2020).

23 Office of Inspector Gen., U.S. Dep’t of Health and Human Servs., Hospital Experiences Responding to the COVID-19 Pandemic: Results of a National Pulse Survey March 23-27, 2020 1-3, 6-7 (2020).

24 See, e.g., Amesh A. Adalja et al., Priorities for the US Health Community Responding to COVID-19, 323 JAMA 1343, 1344 (2020) (calling for testing of “all patients who have unexplained [severe acute respiratory distress syndrome] or severe pneumonia, and … patients who have mid symptoms consistent with COVID-19”).

25 Id.

26 U.S. Food & Drug Admin., FDA Combating COVID-19 with Medical Devices 1 (Aug. 25, 2020), https://www.fda.gov/media/136702/download [https://perma.cc/FR6P-Z3GW].

27 Hahn, supra note 21.

28 U.S. Food & Drug Admin., FDA COVID-19 Response: At-a-Glance Summary 1 (Nov. 20, 2020), https://www.fda.gov/media/137005/download [https://perma.cc/5AGX-A8G5].

29 Hahn, supra note 21.

30 The FDA is a specialized agency within the Department of Health and Human Services (DHHS), authorized and given legal authority by the Food, Drug, and Cosmetic Act (FDCA). See Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301-399g (2018). The Center for Devices and Radiological Health (CDRH) is the FDA division responsible for regulating medical devices. Food & Drug Law Inst., supra note 7, at 94.

31 Food & Drug Law Inst., supra note 7, at 94.

32 Global Engagement, U.S. Food & Drug Admin. 2 (2013), http://www.ipqpubs.com/wp-content/uploads/2013/05/FDA_Global-Engagement.pdf [https://perma.cc/PY4Q-CYAC].

33 What We Do, U.S. Food & Drug Admin. (Mar. 28, 2018), https://www.fda.gov/about-fda/what-we-do#mission [https://perma.cc/34GT-YJ38].

34 Food & Drug Law Inst., supra note 7, at 68.

35 See id. at 83-84.

36 Medical Device Amendments of 1976, Pub. L. No. 94-295, § 2, 90 Stat. 539 (1976).

37 FDCA, 21 U.S.C. § 321(h) (2018). The official definition also includes products recognized in the official National Formulary, the United States Pharmacopeia, or any supplement to them or intended to affect the structure or any function of the body. Id.

38 Food & Drug Law Inst., supra note 7, at 213.

39 Overview of Device Regulation, U.S. Food & Drug Admin. (Sep. 4, 2020), https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation [https://perma.cc/SY5Y-7DAJ].

40 Examples of Class I devices are bandages, examination gloves, and certain surgical implements. Food & Drug Inst., supra note 7, at 213.

41 See FDCA, 21 U.S.C. § 360c(a)(1)A) (2018). General controls include registration and listing, labeling, good manufacturing practices, and premarket notifcation. Id. All Class I devices are exempt from premarket notification requirements except those that are intended for a use that is of substantial importance in preventing the impairment of human health or that presents a potentially unreasonable risk of injury or illness. Id. § 360(l). About 74% of Class I devices are exempt from the premarket notification processes. Classify Your Medical Device, U.S. Food & Drug Admin., https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device [https://perma.cc/V5TY-HZJ3] (last updated Feb. 7, 2020).

42 21 U.S.C. § 360c(a)(1)(B); see also Food & Drug Law Inst., supra note 7, at 68. Examples of Class II devices include powered wheelchairs, infusion pumps, and surgical drapes. Id. at 213. Special controls are usually specific to the device and can include performance standards, postmarket surveillance, patient registries, and 510(k) premarket notification, unless exempt. 21 U.S.C. § 360(k); 21 U.S.C. § 360c(a)(1)(B); see also The Abbreviated 510(k) Program: Guidance for Industry and Food and Drug Administration Staff, U.S. Food & Drug Admin. 4 (2019), https://www.fda.gov/media/72646/download [https://perma.cc/TY8W-GDEG]. For a list of 510(k) exempted Class II devices, see Medical Device Exemptions 510(k) and GMP Requirements, supra note 11.

43 Most Class II devices require a 510(k) Premarket Notification submission at least ninety days before market introduction. 21 U.S.C. § 360(k); Overview of Device Regulation, supra note 39; see also The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]: Guidance for Industry and Food and Drug Administration Staff, U.S. Food & Drug Admin. 3 (2014), https://www.fda.gov/media/82395/download [https://perma.cc/GUT7-6HHX].

44 21 U.S.C. § 360c(i)(1)(A).

45 21 U.S.C. § 360c(f)(2); see also De Novo Classification Request, U.S. Food & Drug Admin., https://www.fda.gov/medical-devices/premarket-submissions/de-novo-classification-request [https://perma.cc/4S8X-3JXU] (last updated Nov. 20, 2019).

46 See Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications, U.S. Food & Drug Admin. (2019), https://www.fda.gov/media/99769/download [https://perma.cc/PRY6-LUC9].

47 21 U.S.C. § 360c(f)(2); see also De Novo Classification Request, supra note 45. However, the de novo review process can often take just as long as the PMA process. Zvi Ladin et al., Boston MedTech Advisors, FDA Review Patterns of ‘De Novo’ Submissions 2 (2010), https://www.bmtadvisors.com/docs/2010_06_10_FDA%20Review%20Patterns%20of%20De%20Novo%20Submissions_Final.pdf [https://perma.cc/7XKE-FRMM]. The FDA proposed a new rule in late 2018 to streamline the de novo process, reduce unnecessary expenditures on industry, and provide structure and clarity. See Medical Device De Novo Classification Process, 83 Fed. Reg. 63,127, 63,127 (Dec. 7, 2018) (to be codified at 21 C.F.R. pt. 860). The proposed rule is part of an effort to reduce 510(k) clearance applications and phase out predicates older than ten years. See Press Release, Scott Gottlieb, Comm’r of Food and Drugs, U.S. Food & Drug Admin., & Jeffrey Shuren, Dir., Ctr. for Devices and Radiological Health, Statement from FDA Comm’r Scott Gottlieb, M.D. and Jeff Shuren, M.D., Dir. of the Center for Devices and Radiological Health, on Transformative New Steps to Modernize FDA’s 510(k) Program to Advance the Review of the Safety and Effectiveness of Medical Devices (Nov. 26, 2018), https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-and-jeff-shuren-md-director-center-devices-and; Maria Rachal, FDA Seeks to Boost Use of De Novo Pathway with Proposed Rule, MedTech Drive (Dec. 5, 2018), https://www.medtechdive.com/news/fda-seeks-to-boost-use-of-de-novo-pathway-with-proposed-rule/543564/ [https://perma.cc/SJB6-P75X].

48 See 21 U.S.C. § 360c(a)(1)(C).

49 21 U.S.C. § 360c(f)(2). Preamendment devices, i.e. Class III devices on the market prior to the MDA, may be marketed through the 510(k) premarket notification process until the FDA requires a PMA.

50 Class III devices on the market prior to the MDA were grandfathered and not subject to the PMA process. 21 U.S.C. § 360e(b)(1)(A). Devices shown to be substantially equivalent to these grandfathered, pre-amendment devices through the 510(k) process are also exempt from the PMA process. 21 U.S.C. § 360e(b)(1)(B). Lastly, the investigational device exemption applies to experimental technology and allows human subject research trials to use unapproved devices. 21 U.S.C. § 360e(a), 360j(g).

51 21 U.S.C. § 360c(a)(1)(C); Medical Device Classification Procedures, 21 C.F.R. § 860.7 (2020). A PMA application will include full reports of all studies on the device, a full description of the device and its components, ingredients, properties, and principles of operation, a full description of the methods and facilities for manufacturing, processing, and packaging the device, samples, proposed labeling, and more. 21 U.S.C. § 360c(e)(c)(1); 21 C.F.R. § 814.20 (2020).

52 21 C.F.R. § 860.7(c)(2). “Isolated case reports, random experience, reports lacking sufficient details to permit scientific evaluation, and unsubstantiated opinions are not regarded as valid scientific evidence to show safety or effectiveness. Such information may be considered, however, in identifying a device with questionable safety or effectiveness.” Id. Non-clinical studies must be conducted in compliance with Good Laboratory Practice for Nonclinical Laboratory Studies, 21 C.F.R. § 58.

53 See 21 U.S.C. § 360c(a)(3)(A).

54 See 21 C.F.R. § 812; see also Overview of Medical Device Classification and Reclassification, U.S. Food & Drug Admin., https://www.fda.gov/about-fda/cdrh-transparency/overview-medical-device-classification-and-reclassification [https://perma.cc/GKW5-LHXE] (last updated Dec. 19, 2017).

55 See 21 U.S.C. § 360i; 21 C.F.R. § 814.84(b)(2).

56 All three classes are subject to various general controls prior to and beyond the approval process. For example, all medical device manufacturers must register their establishments and list their medical devices with the FDA. 21 C.F.R. § 807 (2020). They are subject to the Quality System Regulation and Current Good Manufacturing Practices (CGMPs), establishing requirements for designing, purchasing, manufacturing, packaging, labeling, storing, installing, and servicing. 21 C.F.R. § 820 (2020). Medical devices are also subject to specific labeling requirements. See 21 C.F.R. § 801 (2020). These requirements apply to labels, advertising, and informational literature accompanying the device. Id. The Medical Device Reporting Program is especially important because it requires both manufacturers and user facilities to report adverse events, such as incidents in which a device may have caused or contributed to a death, serious injury, or certain malfunctions. 21 C.F.R. § 803 (2020). The program is intended to detect problems so they can be corrected in an efficient and timely manner. Overview of Medical Device Classification and Reclassification, supra note 54. The FDA can recall its approval of a medical device based this information and must do so if it determines that a device is unsafe or ineffective under the label conditions. FDCA, 21 U.S.C. §§ 360e(e)(1), 360h(e) (2018).

57 See infra Part VI, Section B.

58 See 21 U.S.C. § 360c(f)(2).

59 Learn if a Medical Device Has Been Cleared by FDA for Marketing, U.S. Food & Drug Admin., https://www.fda.gov/medical-devices/consumers-medical-devices/learn-if-medical-device-has-been-cleared-fda-marketing [https://perma.cc/9MJ8-DHCB] (last updated Dec. 29, 2017).

60 Kramer, Xu & Kesselheim, supra note 9, at 1; Inst. of Med., Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years 4 (2011).

61 Heneghan & Thompson, supra note 8, at 187 (referencing Kirsty Sprange & Maxine Clift, The NICE Medical Technologies Evaluation Programme (MTEP): Manufacturer Submission Challenges, 105 J. Royal Soc. Med. S4 (2012)).

62 Inst. of Med., Public Health Effectiveness of the FDA 510(k) Clearance Process: Measuring Postmarket Performance and Other Select Topics: Workshop Report 13 (Theresa Wizemann ed., 2011). More than half of these recalls were due to manufacturing process errors or device design issues. Id.

63 Inst. of Med., supra note 60, at 15.

64 See, e.g., Heneghan & Thompson, supra note 8, at 186-87; How Global Journalists Investigated Medical Device Safety, supra note 14 (finding that the FDA “puts people at risk by pushing devices through an abbreviated approval process, then responds slowly when it comes to forcing companies to correct sometimes life-threatening products.”).

65 See Ctrs. for Devices and Radiological Health, Initial Result of 510(k) Audit: Analysis of Not Substantially Equivalent (NSE) Determinations 2 (2011), https://www.fda.gov/media/92614/download [https://perma.cc/3Z8Q-LCG2].

66 Inst. of Med., supra note 60, at 5.

67 Id. Even more worrisome, a 510(k) application can use a predicate that is old, discontinued, or approved but never marketed. Id.

68 Medtronic, Inc. v. Lohr, 518 U.S. 470, 493 (1996).

69 See Inst. of Med., supra note 60, at 4.

70 See id. at 37.

71 See id. at xii.

72 See id. at 11. A modified de novo review process could provide a scientific and risk-based review of Class II devices while still expediting approval of lower-risk devices. Id.

73 See Press Release, Scott Gottlieb & Jeff Shuren, supra note 47. These changes included increasing expectations for premarket evidence to determine substantial equivalence, implementing a refuse-to-accept policy, improving consistency and thoroughness of review, working to eliminate Class III device 510(k) approval, and eliminating the use of medical devices with safety concerns as predicates. U.S. Food & Drug Admin., FDA Has Taken Steps to Strengthen The 510(k) Program (2018), https://www.fda.gov/media/118500/download [https://perma.cc/K3NE-HXVA].

74 U.S. Food & Drug Admin., supra note 73, at 7.

75 See Inst. of Med., supra note 62. It is debatable, for example, whether the 150% increase in the average number of pages for each 510(k) since 2009 is an improvement to safety and efficacy review or merely a hinderance to manufacturers and innovation.

76 See Medical Device De Novo Classification Process, supra note 47; Press Release, Scott Gottlieb & Jeff Shuren, supra note 47; Rachal, supra note 47.

77 John D. Blum & Jordan Paradise, Public Health Preparedness & Response: An Exercise in Administrative Law, 20 DePaul J. Health Care L. 2, 13 (2018).

78 Project Bioshield Act of 2004, § 2, Pub. L. No. 108-276, 118 Stat. 835 (2004).

79 FDCA § 564, 21 U.S.C. § 360bbb-3 (2018). Subsequent amendments were made by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) § 302(b), 21 U.S.C. § 360bbb-3 (2018), the 21st Century Cures Act of 2016 § 3088, 21 U.S.C. § 360bbb-4a (2018), and Federal Food, Drug, and Cosmetic Act Amendments, Pub. L. No. 115-92, § 1, 131 Stat. 2023 (2017).

80 21 U.S.C. § 360bbb-3. The Secretary of Homeland Security may also identify a material threat sufficient to affect national security or the health and security of U.S. citizens living abroad. Id.

81 Id.

82 These criteria are: (1) The threat in the EUA declaration is capable of causing a serious or life-threatening illness or condition; (2) A reasonable belief based on scientific evidence that the product may be effective in diagnosing, treating, or preventing the illness or condition; (3) The known and potential benefits of the product for the use above outweigh any known and potential risks; and (4) No adequate, approved, and available alternative exists. Id. § 360bbb-3(c); see also U.S. Dep’t of Health and Human Servs., Emergency Use Authorization of Medical Products and Related Authorities: Guidance for Industry and Other Stakeholders 7-8 (2017), https://www.fda.gov/media/97321/download [https://perma.cc/7U58-7FJV] (referring to the risk-benefit analysis of the known and potential benefits and risks as a “‘may be effective’ standard”).

83 21 U.S.C. § 360bbb-3(e)(1)(A)(i). Patients must be informed that the product was authorized under an EUA and about the significant known and potential benefits and risks of the product’s emergency use, the extent to which such benefits and risks are unknown, and the available alternatives to the product, their benefits, and risks. Id.

Recipients must also be informed that they have the option to accept or refuse the EUA product, and about any consequences of such a refusal. Id. § 360bbb-3(e)(1)(A)(ii). The FDA recommends developers requesting an EUA create a fact sheets for providers and patients. U.S. Dep’t of Health and Human Servs., supra note 82, at 22. For more on what this fact sheet should include, see id. at 22-25,

84 21 U.S.C. § 360bbb-3(e)(1)(A)(iii). Such monitoring and reporting conditions may be imposed for an EUA for an unapproved use of an approved product as well. Id. § 360bbb-3(e)(2)(A).

85 21 U.S.C. § 360bbb-3(e)(1)(A)(iv). Records expected to be kept include the names and addresses of facilities receiving the product and the number of doses, devices, or units received. See id.; U.S. Dep’t of Health and Human Servs., supra note 82, at 26. The records and reporting requirements aid in the FDA’s review of the EUA and potential circumstances for its revocation.

86 21 U.S.C. §§ 360bbb-3(e)(1)(B), 360bbb-3(e)(4); see also U.S. Dep’t of Health and Human Servs., supra note 82, at 26-27.

87 See U.S. Dep’t of Health and Human Servs., supra note 82, at 27-28.

88 21 U.S.C. § 360bbb-3(e)(3).

89 Id. For example, a large-scale emergency response may require large numbers of individuals to receive a medical product at locations that are not traditional health care settings, the goal being to dispense the EUA product as quickly as possible to protect the public health. U.S. Dep’t of Health and Human Servs., supra note 82, at 27.

90 21 U.S.C. § 360bbb-3(f).

91 Id. § 360bbb-3(g)(2).

92 U.S. Dep’t of Health and Human Servs., supra note 82, at 29.

93 Id.

94 See 21 U.S.C. § 360bbb-3(m). The categorization will be made if the scientific evidence shows it would be beneficial to protecting the public health and the known and potential benefits of such categorization outweigh the risks. Id. Diagnostic tests are categorized by their complexity as either waived tests, moderate complexity tests, and high complexity tests after clearance or authorization. 21 C.F.R. §§ 493.15(c), 493.17 (2020). The categorization made for an EUA is effective only for the time of the EUA. U.S. Dep’t of Health and Human Servs., supra note 82, at 28; see also FDCA § 564(m), 21 U.S.C. § 360bbb-3(m) (2018).

95 Clinical Laboratory Improvement Amendments, 42 U.S.C. § 263a (2018). CLIA requires certification of clinical laboratories seeking to perform diagnostic testing by the Centers for Medicare and Medicaid Services (CMS). 42 U.S.C. § 263a; 21 C.F.R. § 493 (2020). The FDA, CMS, and CDC are all responsible for executing CLIA and take on unique roles. See Clinical Laboratory Amendments (CLIA), U.S. Food & Drug Admin., https://www.fda.gov/medical-devices/ivd-regulatory-assistance/clinical-laboratory-improvement-amendments-clia [https://perma.cc/463H-HV3C] (last updated Feb. 25, 2020). CMS carries out most of CLIA enforcement, while the CDC is responsible for technical standards, guidance, research, and proficiency testing. See id. CMS’s CLIA responsibilities include issuing laboratory certifications, collecting user fees, conducting inspections, enforcing regulatory compliance, monitoring laboratory performance, publishing CMS rules and regulations, and more. Id. The FDA’s main responsibilities are categorizing tests based on complexity, reviewing requests for waivers, and developing rules and guidance for CLIA laboratories. See id. Diagnostic tests are categorized by their complexity as either waived tests, moderate complexity tests, and high complexity tests after clearance or authorization. 21 C.F.R. §§ 493.15(c), 493.17 (2020). The categorization provided by the FDA in a test’s EUA is independent of that made under CLIA, effective only for the time of the EUA. U.S. Dep’t of Health and Human Servs., supra note 94, at 28; see also FDCA § 564(m), 21 U.S.C. § 360bbb-3(m) (2018).

96 See Ctrs. for Medicare & Medicaid Servs., CLIA Overview 1 (2013), https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/LDT-and-CLIA_FAQs.pdf [https://perma.cc/HF4M-T8X3].

97 See 42 C.F.R. § 493.1253(b)(2); Ctrs. for Medicare & Medicaid Servs., supra note 96.

98 See infra Part IV, Section C, Subsection 1. Currently, CMS is expediting the review process for new CLIA applications, without waiving any application requirements, to ensure laboratories wishing to begin COVID-19 testing may do so as quickly as possible. See Ctrs. for Medicare & Medicaid Servs., supra note 96.

99 See Barbara J. Evans & Ellen Wright Clayton, Deadly Delay: The FDA’s Role in America’s COVID-Testing Debacle, 130 Yale L.J.F. 78, 82-84 (2020) (concluding “the FDA lacked clear statutory authority to require EUAs for LDTs” while recognizing the debate over statutory authority).

100 See Public Readiness and Emergency Preparedness Act, § 319, 42 U.S.C. § 247d (2018).

101 Id. § 247d-6d.

102 See Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, 85 Fed. Reg. 15,198 (Mar. 17, 2020).

103 Coronavirus Aid, Relief, and Economic Security Act § 3103, 42 U.S.C. § 247d-6d(i)(1)(D) (2020). These new covered countermeasures include respiratory protective devices approved by NIOSH or any successor regulations. Id. The Secretary subsequently amended the PREP Act Declaration to extend liability immunity to these devices. Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, 85 Fed. Reg. 21,012 (Apr. 15, 2020).

104 Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, 85 Fed. Reg. at 21,012. The PREP Act Declaration also gives liability immunity to devices used in the administration of the covered products and all components and materials involved. Id.

105 See U.S. Can Boost Domestic Production of Essential Medicines and Their Ingredients with Tax Incentives, Ways and Means Committee (Aug. 6, 2020), https://gop-waysandmeans.house.gov/u-s-can-boost-domestic-production-of-essential-medicines-and-their-ingredients-with-tax-incentives/ [https://perma.cc/U2FB-B8LA].

106 Office of Inspector Gen., U.S. Dep’t of Health & Human Servs., supra note 23, at 3-4.

107 See Product Classification Database, U.S. Food & Drug Admin., https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm [https://perma.cc/MU5S-LJS9] (last visited Oct. 24, 2020) (searching “face mask,” “facemask,” and “respirator”); see also Ctr. for Devices and Radiological Health, U.S. Food & Drug Admin., Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised): Guidance for Industry and Food and Drug Administration Staff 3 (May 2020), https://www.fda.gov/media/136449/download [https://perma.cc/Z92P-NCRF].

108 Letter from Denise M. Hinton, Chief Scientist, Food & Drug Admin., to Robert R. Redfield, Dir., Ctrs. for Disease Control and Prevention (Mar. 28, 2020), https://www.fda.gov/media/135763/download [https://perma.cc/TD7S-FUYA].

109 Letter from Denise M. Hinton, Chief Scientist, Food & Drug Admin., to Manufacturers of Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators, Health Care Personnel, Hospital Purchasing Departments and Distributors, Importers and Commercial Wholesalers, and Any Other Applicable Stakeholders (June 6, 2020), https://www.fda.gov/media/136403/download [https://perma.cc/EYH4-WVKL].

110 Letter from Denise M. Hinton, Chief Scientist, Food & Drug Admin., to Manufacturers of Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators manufactured in China, Health Care Personnel, Hospital Purchasing Departments and Distributors, Importers and Commercial Wholesalers, and Any Other Applicable Stakeholders (Oct. 15, 2020), https://www.fda.gov/media/136664/download [https://perma.cc/FWB7-AGSD].

111 Letter from Denise M. Hinton, Chief Scientist, Food & Drug Admin., to Manufacturers of Face Masks, Health Care Personnel, Hospital Purchasing Departments and Distributors, and Any Other Stakeholders (Apr. 24, 2020), https://www.fda.gov/media/137121/download [https://perma.cc/T6PL-Y76P]. This umbrella EUA covers face masks used for a medical purpose intended as source control and neither labeled as a surgical mask nor intended to provide liquid barrier protection. Id.

112 Ctr. for Devices and Radiological Health, supra note 107, at 6, 8. A face mask not intended to provide liquid barrier protection would be considered to not pose an undue risk to the public health where appropriate labeling is used, the labeling makes recommending against certain uses, and the labeling does not include uses for infection prevention. Id. at 6. A surgical mask intended to provide liquid barrier protection would be considered to not pose an undue risk to the public health where the mask meets fluid resistance testing and flammability requirements, includes appropriate labeling, and is not intended for uses like infection prevention. Id. at 8.

113 Id.

114 Id.

115 Id. at 9.

116 Id.

117 NPPTL Respirator Assessments to Support the COVID-19 Response, Ctrs. Disease Control (Dec. 3, 2020), https://www.cdc.gov/niosh/npptl/respirators/testing/NonNIOSHresults.html [https://perma.cc/H5DZ-HRMC].

118 Id.

119 Id.

120 Ctr. for Devices and Radiological Health, supra note 107, at 9.

121 Id.

122 Ranney, supra note 18, at e41(1); see also Office of Inspector Gen., U.S. Dep’t of Health and Human Servs., supra note 23, at 6-7.

123 Ranney, supra note 18, at e41(1).

124 Id.

125 Medical Device Shortages During the COVID-19 Public Health Emergency, U.S. Food & Drug Admin. (Sep. 24, 2020), https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/medical-device-shortages-during-covid-19-public-health-emergency#shortage [https://perma.cc/7PFX-9V8K]. The Federal CARES Act amended the Food, Drug, and Cosmetic Act to add § 506J, giving the FDA authority to help prevent or mitigate medical device shortages during public health emergencies. See Coronavirus Aid, Relief, and Economic Security Act, Pub. L. No. 116-136, § 3121, 134 Stat. 281, 363-64 (2020); 21 U.S.C. § 356j (2020). § 356j(g) requires the FDA to maintain a publicly available and up-to-date list of devices determined to be in shortage. 21 U.S.C. § 356j(g) (2020).

126 Faiz Siddiqui, The U.S. Forced Major Manufacturers to Build Ventilators. Now They’re Piling Up Unused in a Strategic Reserve, Wash. Post (Aug. 18, 2020), https://www.washingtonpost.com/business/2020/08/18/ventilators-coronavirus-stockpile/[https://perma.cc/7RXC-7PDV].

127 Andrew Jacobs, Now the U.S. Has Lots of Ventilators, but Too Few Specialists to Operate Them, N.Y. Times (Nov. 22, 2020), https://www.nytimes.com/2020/11/22/health/Covid-ventilators-stockpile.html [https://perma.cc/7ZB7-G4SG].

128 Letter from Denise M. Hinton, Chief Scientist, Food & Drug Admin., to Manufacturers and Other Stakeholders (Mar. 24, 2020), https://www.fda.gov/media/136423/download [https://perma.cc/UN7T-PD4L].

129 See Product Classification Database, U.S. Food & Drug Admin., https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm [https://perma.cc/2APC-GA9F] (last visited Oct. 24, 2020) (providing a search engine to find medical device names, product codes, and product classification and searching “ventilator”).

130 Id.

131 Letter from Denise M. Hinton to Manufacturers and Other Stakeholders, supra note 122; see also 21 C.F.R. § 820 (2020) (including requirements with respect to design, manufacture, packaging, labeling, storage, and distribution). The authorization conditions for all EUAs are outlined in the FDCA § 564(e)(1)(A), 21 U.S.C. § 360bbb-3 (2017).

132 Ctr. for Devices and Radiological Health, U.S. Food & Drug Admin., Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff 13 (Mar. 2020), https://www.fda.gov/media/136318/download [https://perma.cc/9Z8S-X2E3].

133 Amanda Kobokovich, Ctr. for Health Sec., John Hopkins Bloomberg Sch. of Pub. Health, Ventilator Stockpiling and Availability in the U.S. 1 (2020), https://www.centerforhealthsecurity.org/resources/COVID-19/COVID-19-fact-sheets/200214-VentilatorAvailability-factsheet.pdf [https://perma.cc/FZ2N-3EY6].

134 See generally Robert M. Kacmarek, The Mechanical Ventilator: Past, Present, and Future, 56 Respiratory Care, 1170, 1170-78 (2011) (providing background on the development of ventilators).

135 In fact, the FDA is working to promptly issue 510(k) approvals for new and modified ventilators.

136 See infra Part VI, Section B.

137 See, e.g., Eric Schneider, Failing the Test – The Tragic Gap Undermining the U.S. Pandemic Response, 383 New. Eng. J. Med. 299, 301 (2020). Schneider explains:

Testing has many purposes beyond diagnosis and protection of health care workers. Testing data are needed to manage all aspects of a pandemic. For instance, they are a cornerstone of epidemic forecasting models, which are sorely needed to reveal the future demand for care, including the timing of case surges and the magnitude of required emergency medical services, hospital staff, hospital beds, ventilator equipment, and mortuary services. Without good testing data, forecasters have to rely on guesswork and assumptions.

Id.

138 See, e.g., David M. Studdert & Mark A. Hall, Disease Control, Civil Liberties, and Mass Testing —Calibrating Restrictions during the Covid-19 Pandemic, 383 New Eng. J. Med. 102, 103-4 (2020) (advocating for a comprehensive testing program as a less intrusive response to the pandemic than restrictions such as stay-at-home orders). “In ordinary times, a comprehensive program of testing, certification, and retesting would be beyond the pale. Today, it seems like a fair price to pay for safely and fairly resuming a semblance of normal life.” Id.

139 See, e.g., Schneider, supra note 137, at 300. A recent Rockefeller Foundation report estimates that at least 193 million tests are need monthly to support reopening schools and nursing homes, with modified conditions and restrictions, safely. Christina Silcox et al., A National Decision Point: Effective Testing and Screening for COVID-19 16 (2020), https://www.rockefellerfoundation.org/wp-content/uploads/2020/09/A-National-Decision-Point-Effective-Testing-Screening-for-Covid-19-Full-Report.pdf [https://perma.cc/KCD4-ZFNZ]. The Harvard Global Health Institute and Brown School of Public Health suggest a nationwide testing target of almost 4.4 million tests per day, with an ideal target of 14 million, to effectively contain the spread of COVID-19. Rob Stein, Can the U.S. Use Its Growing Supply of Rapid Tests to Stop the Virus?, NPR (Oct. 2020, 5:03 a.m.), https://www.npr.org/sections/health-shots/2020/10/01/915793729/can-the-u-s-use-its-growing-supply-of-rapid-tests-to-stop-the-virus [https://perma.cc/ZW3G-3PU3]. For an update on these targets, which varies over time as infection rates change, see Viral Testing Targets, Pandemics Explained, https://globalepidemics.org/testing-targets/ [https://perma.cc/XS98-CG7F] (providing an updated interactive map module and testing calculator).

140 Office of Inspector Gen., U.S. Dep’t of Health and Human Servs., supra note 23, at 1.

141 Id. Hospitals were unable to meet testing demands because they lacked the necessary supplies such as nasal swabs, viral transfer media, and reagents used to detect the virus. Id.

142 Id. at 1-2.

143 U.S. Food & Drug Admin., supra note 26, at 1.

144 See Shawn Boburg et al., Inside the Coronavirus Testing Failure: Alarm and Dismay Among the Scientists who Sought to Help, Wash. Post (Apr. 3, 2020), https://www.washingtonpost.com/investigations/2020/04/03/coronavirus-cdc-test-kits-public-health-labs/?arc404=true [https://perma.cc/SK5J-LN4C]; Rachana Pradhan, CDC Coronavirus Testing Decision Likely To Haunt Nation For Months To Come, Kaiser Health News (Mar. 23, 2020), https://khn.org/news/cdc-coronavirus-testing-decision-likely-to-haunt-nation-for-months-to-come/ [https://perma.cc/ML3B-U895].

145 Letter from Denise M. Hinton, Chief Scientist, Food & Drug Admin., to Robert R. Redfield, Director, Ctrs. for Disease Control and Prevention (Mar. 15, 2020) (amending the initial February 4, 2020 EUA). The name of the test is the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel. Id.

146 Boburg et al., supra note 144.

147 Id.; Pradhan, supra note 144.

148 Boburg et al., supra note 144.

149 Id.; Pradhan, supra note 144. Many labs discovered solutions to make the tests work on their own but could not go ahead with the changes under guidance at the time. Id.

150 Coronavirus (COVID-19) Update: FDA Issues New Policy to Help Expedite Availability of Diagnostics, U.S. Food & Drug Admin. (Feb. 29, 2020), https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-new-policy-help-expedite-availability-diagnostics [https://perma.cc/B6S9-8DMU].

151 Boburg et al., supra note 144.

152 In a January 15, 2020 conference call, leading CDC scientists assured public health officials and scientists that their goal was to get FDA approval as quickly as possible. See id.

153 Letter from Stephen Hahn, Commissioner of Food and Drugs, U.S. Food & Drug Admin., to Grace Kubin, Director, Tex. Dep’t of State Health Servs., & Scott J. Becker, Chief Exec. Officer, Ass’n of Pub. Health Labs. (Feb. 26, 2020), https://context-cdn.washingtonpost.com/notes/prod/default/documents/1bbf4d0e-8c11-4126-b3af-24a0575c0012/note/076de12e-172d-49e5-8c50-883688f9c999.#page=1 [https://perma.cc/YKW5-CLC8].

154 Id.; see also Boburg et al., supra note 144; Pradhan, supra note 144.

155 U.S. Food & Drug Admin., supra note 26, at 1. PCR testing involves “a molecular testing technique that detects genetic material from the virus” to diagnose active COVID-19 infections. Id. Some PCR tests are automated and require limited training to perform. Id. These tests are typically performed by laboratories operating under a CLIA Certificate of Waiver. Id. Other PCR tests require highly trained operators to manually perform and are authorized for use by laboratories certified to perform complex tests. Id. Molecular diagnostic test systems, which are used to run PCR tests, are generally classified as Class I devices and exempt from the 510(k) approval process. See Product Classification Database, supra note 129 (searching “molecular test”).

156 U.S. Food & Drug Admin., supra note 26, at 1. Antigen diagnostic tests rapidly detect proteins from the SARS-CoV-2 virus that causes COVID-19. Id. Coronavirus antigen tests are unclassified by the FDA because they are pre-amendment devices. See Product Classification Database, supra note 129 (searching “antigen test”).

157 U.S. Food & Drug Admin., supra note 28, at 1.

158 Letter from Denise M. Hinton, Chief Scientist, Food & Drug Admin., to Laboratories Who Have Developed a Molecular-Based Test (LDTs) for Coronavirus Disease 2019 (COVID-19) (Mar. 31, 2020), https://www.fda.gov/media/136598/download [https://perma.cc/8768-AH6M]. LDTs under this EUA, as with any other EUA under the FDCA, are subject to certain conditions of authorization, including reporting to public health authorities, tracking adverse events, and collecting information on performance. Id. FDA produced fact sheets for both healthcare providers and patients are required to accompany results reports from LDTs under the EUA. Id.; see also U.S. Food & Drug Admin., Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests (2020), https://www.fda.gov/media/136599/download [https://perma.cc/9WB6-E2NT]; U.S. Food & Drug Admin., Fact Sheet for Patients: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests (2020), https://www.fda.gov/media/136600/download [https://perma.cc/UPV6-JFZF].

159 Id.

160 Id. To view the template, see In Vitro Diagnostics EUAs, U.S. Food and Drug Admin., https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas [https://perma.cc/9PL3-SQ5G] (last updated Mar. 17, 2021) (providing a link to download the template under “Molecular Diagnostic Template for Laboratories”).

161 Ctr. for Devices and Radiological Health, U.S. Food & Drug Admin., Policy for Coronavirus Disease-2019: Tests During the Public Health Emergency (Revised) 7 (May 11, 2020), https://www.fda.gov/media/135659/download [https://perma.cc/6D2D-BL5W]. After validation notification, a CLIA laboratory only has fifteen business days to prepare the EUA submission before the FDA removes the laboratory from its notification list and takes other actions. Id.

162 To view Appendix A, see In Vitro Diagnostics EUAs, supra note 160 (providing an updated list of approved LDTs under the CLIA EUA).

163 Evans & Clayton, supra note 99, at 94.

164 Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests, U.S. Dep’t of Health and Human Servs. (Sep. 1, 2020), https://www.hhs.gov/coronavirus/testing/recission-guidances-informal-issuances-premarket-review-lab-tests/index.html [https://perma.cc/QA3F-UY6C].

165 Id. The notice cited the decision was consistent with the President’s Executive Order on Reducing Regulation and Controlling Regulatory Costs, 82 Fed. Reg. 9,339, 9,339 (Feb. 2, 2017), and Executive Order on Regulatory Relief to Support Economic Recovery, 85 Fed. Reg. 31,353, 31,353 (May 22, 2020).

166 Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests, supra note 164.

167 Id.; see also Clinical Laboratory Improvement Amendments of 1988, 42 U.S.C. § 263a (2018); 42 C.F.R. § 493 (2020).

168 FAQs on Testing for SARS-CoV-2, U.S. Food & Drug Admin., https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/faqs-testing-sars-cov-2#general [https://perma.cc/28JS-5XFZ] (last updated Oct. 21, 2020). Instead, the FDA is focusing its efforts by prioritizing EUA review for point of care tests, home collection tests, and at-home tests to increase testing accessibility as well as tests that would significantly increase testing capacity, such as through wide distribution or reduced reliance on testing supplies. Id.

169 Coronavirus Aid, Relief, and Economic Security Act, § 3202, 42 U.S.C. § 256b (2020).

170 See Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, 85 Fed. Reg. 21,012 (Apr. 15, 2020).

171 Understanding the Regulatory Terminology of Potential Preventions and Treatments for COVID-19, U.S. Food & Drug Admin., https://www.fda.gov/media/138490/download [https://perma.cc/DT88-5HKL] (last updated Oct. 2020).

172 Greg Slabodkin, In Shift, FDA Ordered to Provide ‘Timely’ EUA Reviews for COVID-19 Lab Developed Tests, MedTech Dive (Nov. 17, 2020), https://www.medtechdive.com/news/giroir-directs-fda-to-provide-timely-eua-reviews-for-covid-19-lab-develop/589159/#:~:text=FDA%20Monday%20updated%20its%20FAQ,for%20agency%20review%20and%20authorization [https://perma.cc/H8ZM-VW62].

173 FAQs on Testing for SARS-CoV-2, supra note 168.

174 Ctr. for Devices and Radiological Health, supra note 161, at 11.

175 See id.

176 Id.

177 Id.

178 Id.

179 Id.

180 For example, the FDA has limited oversight over drug compounding as it has allowed state boards of pharmacy to be the primary regulators of drug compounding practices. Nat’l Acads. of Scis., Eng’g, & Med. et al., Gaps in Regulation, Oversight, and Surveillance, in Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectivness, and Use 73 (2020). The lack of FDA oversight and support for state handling of drug compounding eventually led to the New England Compounding Center meningitis outbreak, killing over 64 people and infecting over 753. Id. at 81. Immediate legislative efforts under the Drug Quality and Security Act of 2013 were made to grant the FDA more authority over drug compounding. Id.

181 FAQs on Testing for SARS-CoV-2, supra note 168. These states and territories include Puerto Rico, Colorado, Connecticut, Maryland, Mississippi, Nevada, New Jersey, New York, and Washington State. Id.

182 See Emergency Use Authorization--Archived Information, Food & Drug Admin., https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization-archived-information [https://perma.cc/TT4D-W387] (last updated Oct. 22, 2020). The EUA for the CDC’s diagnostic test, however, has been amended multiple times to fix its faulty design. See Letter from Uwe Scherf, Director, Division of Microbiology Devices, Ctr. for Devices and Radiological Health, to Wendi Kuhnert-Tallman, EOC Laboratory Task Force Lead, Ctrs. for Disease Control and Prevention (June 12, 2020); Letter from Uwe Scherf, Director, Division of Microbiology Devices, Ctr. for Devices and Radiological Health, to Wendi Kuhnert-Tallman, EOC Laboratory Task Force Lead, Ctrs. for Disease Control and Prevention (July 13, 2020).

183 Steven Woloshin et al., False Negative Tests for SARS-CoV-2 Infection – Challenges and Implications, 383 New Eng. J. Med. e38(1), e38(2)-(3) (2020) (suggesting that tests should have at least 95% sensitivity to be reliable and useful in a large-scale testing effort).

184 See id.

185 See Interim Guidance for Rapid Antigen Testing for SARS-CoV-2, Ctrs. for Disease Control & Prevention (Sep. 4, 2020), https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antigen-tests-guidelines.html [https://perma.cc/3E6N-QU9G].

186 Andrea Prinzi, How the SARS-CoV-2 EUA Antigen Tests Work, Am. Society For Microbiology (Aug. 31, 2020), https://asm.org/Articles/2020/August/How-the-SARS-CoV-2-EUA-Antigen-Tests-Work [https://perma.cc/9J9B-PW4X].

187 Steven Woloshin et al., supra note 183, at e38(2)-(3) (utilizing the Bayes’ theorem to describe how COVID-19 test accuracy and pretest probability of infection interact in estimating false negative probability).

188 Ingrid Arevalo-Rodriguez et al., False-Negative Results of Initial RT-PCR Assays for COVID-19: A Systematic Review 4 (Working Paper, Aug. 13, 2020), https://www.medrxiv.org/content/10.1101/2020.04.16.20066787v2.full.pdf+html [https://perma.cc/A398-4KVD].

189 Woloshin et al., supra note 183, at e38(2)-(3) (describing how use of known or contrived samples in validation studies, as currently permitted by the FDA, may lead to overestimates of test sensitivity).

190 Id.

191 Zika Virus Diagnostic Development, U.S. Food & Drug Admin. (Nov. 26, 2019), https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/zika-virus-diagnostic-development#:~:text=As%20of%20December%2012%2C%202018,IgM)%20antibodies%20in%20human%20blood [https://perma.cc/VX8K-KYMN].

192 Nick Paul Taylor, Ex-FDA Chief Scientist Slams ‘Chaos’ Caused by Agency Approach to Antibody Tests, MedTech Dive, June 10, 2020, https://www.medtechdive.com/news/ex-fda-chief-scientist-slams-chaos-caused-by-agency-approach-to-antibody/579527/#:~:text=A%20former%20FDA%20chief%20scientist,approach%20to%20regulating%20the%20field [https://perma.cc/BUM6-GUAH].

193 U.S. Food & Drug Admin., supra note 26, at 1.

194 U.S. Food & Drug Admin., supra note 28, at 1. Serology tests in general are unclassified because they are pre-amendment devices, while antibody test systems are Class II devices. See Product Classification Database, supra note 129 (searching “serology”). Serology tests for more serious conditions, such as a Hepatitis B, are Class III devices. Id.

195 U.S. Food & Drug Admin., supra note 26, at 1.

196 Anand Shah & Jeff Shuren, U.S. Food & Drug Admin., Insight into FDA’s Revised Policy on Antibody Tests: Prioritizing Access and Accuracy (May 4, 2020), https://www.fda.gov/news-events/fda-voices/insight-fdas-revised-policy-antibody-tests-prioritizing-access-and-accuracy [https://perma.cc/46B5-WDE7].

197 Convaslescent plasma therapy, an immunotherapy applied to the treatment of infectious diseases for over a century, involves transfusing blood plasma containing SARS-CoV-2 antibodies from a recovered individual into an infected individual. Kai Duan et al., Effectiveness of Convalescent Plasma Therapy in Severe COVID-19 Patients, 117 Proc. Nat’l Acad. Sci. 9490, 9490-91 (2020). Though still experimental and awaiting clinical trial results for full FDA approval, early studies suggest that convalescent plasma “can be an easily accessible, promising, and safe rescue option for severe COVID-19 patients.” Id. The FDA issued an EUA for the use of convalescent plasma, a biologic, on August 23, 2020. Letter from Denise M. Hinton, Chief Scientist, Food & Drug Admin., to Robert P. Kadlec, Assistant Sec’y for Preparedness and Response, U.S. Dep’t of Health & Human Servs. (Aug. 23, 2020).

198 Beatriz Boger Msc et al., Systematic review with meta-analysis of the accuracy of diagnostic tests for COVID-19, Am. J. Infection Control 21, 28 (2021).

199 See, e.g., Mayara Lisboa Bastos et al., Diagnostic Accuracy of Serological Tests for COVID-19: Systematic Review and Meta-Analysis, 370 BMJ, no. 2516, July 2020, at 2, 9 (finding that even three weeks after symptom onset, serological tests can misclassify 30% of results and concluding that “current serological tests for covid-19 have limited utility in the diagnosis of acute covid-19.”); Beatriz Boger Msc et al., supra note 198, at 28 (“[T]he use of serological tests for detection in the initial/acute phase of the disease can be challenging.”); Rodolfo Castro et al., COVID-19: A Meta-analysis of Diagnostic Test Accuracy of Commercial Assays Registered in Brazil, 24 Brazilian J. Infectious Diseases 180, 187 (2020) (finding a range of 10-40% of false-negative results in the acute phase of eight evaluated tests marketed in Brazil); J. J. Deeks et al., Cochrane Library: Cochrane Database of Systematic Reviews, Antibody Tests for Identification of Current and Past Infection with SARS-CoV-2 (Review) 4 (2020) (finding that antibody tests detected only 30% of people who had COVID-19 one week after first symptoms compared to 90% after three weeks, giving false positive results in 2% of those who did not have COVID-19. If 1,000 people had antibody tests, 21% would have false positive results and 0.4% would have false negative results).

200 Anand Shah & Jeff Shuren, supra note 196.

201 Bastos et al., supra note 199, at 12.

202 Letter from Denise M. Hinton, Chief Scientist, Food & Drug Admin., to Frank Lou, Director, Azure Biotech Inc. (Sep. 23, 2020), https://www.fda.gov/media/139789/download [https://perma.cc/PC6E-YMYG]. The Assure COVID-19 IgG/IgM Rapid Test Device was first granted an EUA in July 2020 and then reissued an EUA authorizing point-of-care testing in September 2020. Id. The authorization allows the test to be used in care settings like doctor’s offices, hospitals, urgent care centers, and emergency rooms without the need of a central lab for testing. Id.

203 Stephen M. Hahn, Coronavirus (COVID-19) Update: FDA Provides More Regulatory Relief During Outbreak, Continues to Help Expedite Availability of Diagnostics, U.S. Food & Drug Admin. (Mar. 16, 2020), https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-provides-more-regulatory-relief-during-outbreak-continues-help [https://perma.cc/45BY-SER8]. The policy required that serological tests include warning statements noting that the test was not FDA approved and should not be used to inform infection status. Id.

204 Ctr. for Devices and Radiological Health, supra note 161, at 7.

205 Letter from Denise M. Hinton, Chief Scientist, Food & Drug Admin., to Manufacturers and Other Stakeholders (Apr. 28, 2020), https://www.fda.gov/media/137470/download [https://perma.cc/VF4G-SWZG]. Tests eligible for this authorization included lateral flow or enzyme-linked immunosorbent assay (ELISA) tests. Id.

206 Ctr. for Devices and Radiological Health, supra note 161, at 7.

207 Comm. on Oversight and Reform, 116th Cong., Memorandum: Preliminary Findings of the Subcommittee’s Coronavirus Antibody Testing Investigation 1 (Comm. Print. Apr. 24, 2020).

208 Hahn, supra note 203.

209 Bastos et al., supra note 199, at 9.

210 Memorandum: Preliminary Findings of the Subcommittee’s Coronavirus Antibody Testing Investigation, supra note 207 at 1.

211 Id.

212 Press Release, House Comm. on Oversight and Reform, Subcommittee Briefing Examined State of Coronavirus Antibody Testing (June 9, 2020), https://oversight.house.gov/news/press-releases/subcommittee-briefing-examined-state-of-coronavirus-antibody-testing [https://perma.cc/FB3M-EUMC]. “Dr. Jesse Goodman, former FDA Chief Scientist, stated that health agencies ‘stumbled’ with early decisions on diagnostic testing, and ‘chaos’ in antibody tests ensued when ‘both qualified and unqualified entities flooded the market with tests.’” Id.

213 Letter from Raja Krishnamoorthi, Chairman, Subcomm. on Economic and Consumer Policy, 116th Cong., to Stephen M. Hahn, Comm’r, U.S. Food & Drug Admin. (Apr. 28, 2020), https://oversight.house.gov/sites/democrats.oversight.house.gov/files/2020-04-28.RK%20to%20Hahn-FDA%20re%20%20Serology%20Tests.pdf [https://perma.cc/843P-6DPV].

214 Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency, 85 Fed. Reg. 29,461, 29,462 (May 15, 2020); see also Ctr. for Devices and Radiological Health, supra note 161, at 7.

215 Ctr. for Devices and Radiological Health, supra note 161, at 14-15.

216 Id. at 15, 20. Specificity is “the ability of a test to correctly identify people without the disease” while sensitivity is “the ability of a test to correctly identify patients with a disease.” Amelia Swifte et al., What Are Sensitivy and Specificity?, 23 Evidence Based Nursing 2, 3 (2020).

217 Id.

218 EUA Authorized Serology Test Performance, U.S. Food & Drug Admin., https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/eua-authorized-serology-test-performance [https://perma.cc/S3V4-JXN4] (last updated Dec. 7, 2020); see also Coronavirus (COVID-19) Update: FDA Publicly Shares Antibody Test Performance Data From Kits as Part of Validation Study, U.S. Food & Drug Admin. (June 4, 2020), https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-publicly-shares-antibody-test-performance-data-kits-part-validation [https://perma.cc/6M2E-6CZN].

219 Letter from Denise M. Hinton, Chief Scientist, Food & Drug Admin., to Manufacturers and Other Stakeholders (July 21, 2020), https://www.fda.gov/media/140351/download#:~:text=Instead%2C%20FDA%20will%20issue%20individual,)(C)%20of%20the%20Act [https://perma.cc/5NJ4-5MBM] (revoking the EUA issued for certain serological tests).

220 Id.

221 Id.

222 Letter from Denise M. Hinton, Chief Scientist, Food & Drug Admin., to Andre Hsiung, Autobio Diagnostics Co., Ltd. (Aug. 6, 2020), https://www.fda.gov/media/140908/download [https://perma.cc/N94H-L58J]; Letter from Denise M. Hinton, Chief Scientist, Food & Drug Admin., to Louise M. Sigismondi, Chembio Diagnostic Systems, Inc. (June 16, 2020), https://www.fda.gov/media/139109/download [https://perma.cc/TH8L-BSQY].

223 Id.

224 See EUA Authorized Serology Test Performance, supra note 218.

225 Certain COVID-19 Serology/Antibody Tests Should Not Be Used - Letter to Clinical Laboratory Staff and Health Care Providers, U.S. Food & Drug Admin. (June 19, 2020), https://www.fda.gov/medical-devices/letters-health-care-providers/certain-covid-19-serologyantibody-tests-should-not-be-used-letter-clinical-laboratory-staff-and [https://perma.cc/4EZ9-LXPV].

226 Id.

227 Id.

228 See Brooke Courtney, Susan Sherman, & Matthew Penn, Federal Legal Preparedness Tools for Facilitating Medical Countermeasure Use During Public Health Emergencies, 41 J.L. Med. & Ethics 22, 24 (2013).

229 See id.; see also supra Part IV.

230 See supra Part IV.

231 U.S. Dep’t of Health and Human Servs., supra note 82, at 7-8.

232 See supra Part IV, Section C (discussing the botched testing effort after the CDC’s initial test malfunctioned).

233 “In the context of a public health emergency [involving pandemic infectious disease], it is critically important that tests are validated because false results can negatively impact not only the individual patient but also can have broad public health impact.” Ctr. for Devices and Radiological Health, supra note 161, at 7-8.

234 See Food & Drug Law Inst., supra note 7, at 68.

235 Emergency Use Authorization--Archived Information, U.S. Food & Drug Admin., https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization-archived-information#anthrax [https://perma.cc/2CWJ-2WVE] (last updated Dec. 4, 2020).

236 Blum & Paradise, supra note 77, at 18. The FDA has issued 19 EUAs for Zika detection assays. Id.

237 See Zika Response Updates from FDA, U.S. Food & Drug Admin., https://wayback.archive-it.org/7993/20190422171620/https://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/MCMIssues/ucm485199.htm#bydate [https://perma.cc/QD9U-Y5VN] (last updated Apr. 19, 2019).

238 See Boburg et al., supra note 137; Pradhan, supra note 137.

239 Triple Testing: CDC Works Rapidly to Develop Unprecedented Zika Test, Ctrs. for Disease Control (Aug. 16, 2016), https://www.cdc.gov/about/24-7/cdcresponders-zika/elisa.html [https://perma.cc/2KUQ-66S6].

240 See Emergency Use Authorizations for Medical Devices, U.S. Food & Drug Admin., https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations-medical-devices [https://perma.cc/DDN9-K7LX] (last updated July 29, 2020); Emergency Use Authorization--Archived Information, U.S. Food & Drug Admin., https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization-archivedinformation#zika [https://perma.cc/NQ8N-FF39] (last updated Dec. 4, 2020) (refer to “Zika Virus EUA – ARCHIVED INFORMATION”); see also supra Part IV, Section C (discussing the malfunctioning of the initial CDC test and the delay of testing efforts as a result).

241 See Blum & Paradise, supra note 77, at 18. While it is difficult to compare FDA testing responses to Zika and COVID-19 because the Zika virus does not have the potential to reach such mass levels of global impact, the Zika testing EUAs seemed to be subject to more review while also having more immediate positive outcomes.

242 Zika Virus Diagnostic Development, supra note 191. Recognizing the serious implications of Zika for certain populations, the FDA is encouraging Zika LDT developers to submit an EUA request. Id.

243 Id. The FDA requests that developers “submit information about their tests to help FDA better understand their design, validation, and performance characteristics.” Id.

244 See supra Part IV, Section C.

245 Nick Schwellenbach, CDC Whistleblower Identified the “Fatal Flaw” in Testing Years Ago, Project on Government Oversight (June 4, 2020), https://www.pogo.org/investigation/2020/06/cdc-whistleblower-identified-the-fatal-flaw-in-testing-years-ago/ [https://perma.cc/F2Q4-Z27V].

246 See supra notes 94-99 and accompanying text; see also Zika Virus Diagnostic Development, supra note 191.

247 See Zika Virus Diagnostic Development, supra note 191.

248 Id.

249 Laboratory Developed Tests, U.S. Food & Drug Admin., https://www.fda.gov/medical-devices/vitro-diagnostics/laboratory-developed-tests [https://perma.cc/M4A3-W4HG] (last updated Sept. 17, 2018).

250 See Evans & Clayton, supra note 99, at 82.

251 See Evans & Clayton, supra note 99, at 82, 87 (citing Paul D. Clement & Lawrence H. Tribe, Laboratory Testing Services, as the Practice of Medicine, Cannot Be Regulated as Medical Devices, Am. Clinical Lab. Ass’n (Jan. 7, 2015), https://www.acla.com/wp-content/uploads/2o15/ol/Tribe-Clement-White-Paper-6-15.pdf [https://perma.cc/4ET9-UAU7]; Jeffrey S. Mohlman et al., Laboratory-Developed Tests: A Legislative and Regulatory Review, 63 Clinical Chemistry 1575, 1582 (Oct. 2017)).

252 FDCA, 21 U.S.C. § 321(h) (2018) (emphasis added); see also Evans & Clayton, supra note 99, at 88.

253 See U.S. Food & Drug Admin., Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories: Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) 6 (2014), https://www.fda.gov/media/89841/download [https://perma.cc/JT6E-QL6H]; Laboratory Developed Tests, supra note 239.

254 U.S. Food & Drug Admin., supra note 253, at 6-7.

255 See Laboratory Developed Tests, supra note 239.

256 U.S. Food & Drug Admin., Discussion Paper on Laboratory Developed Tests (LDTs) 1 (2017), https://www.fda.gov/media/102367/download [https://perma.cc/6AYV-6XFV].

257 See Zika Virus Diagnostic Development, supra note 181.

258 See Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests, supra note 164.

259 Id.; see also Evans & Clayton, supra note 99, at 82.

260 Slabodkin, supra note 172.

261 In fact, the FDA’s back and forth oversight policies for LDTs are likely direct responses to criticism from both sides of the LDT regulatory debate.

262 See supra Part IV, Section C; see also Evans & Clayton, supra note 99, at 84-85.

263 “The FDA is aware of fault LDTs that could have led to: patients being over- or undertreated for heart disease; cancer patients being exposed to inappropriate therapies or not getting effective therapies; incorrect diagnosis of autism; unnecessary antibiotic treatments; and exposure to unnecessary, harmful treatments for certain diseases such as Lyme disease.” Laboratory Developed Tests, supra note 249.

264 VALID Act of 2020, S. 3404, 116th Cong. (2020).

265 VITAL Act of 2020, S. 3512, 116th Cong. (2020).

266 See VALID Act of 2020, S. 3404, 116th Cong. (2020).

267 See VITAL Act of 2020, S. 3512, 116th Cong. (2020).

268 See id.

269 See U.S. Food & Drug Admin., supra note 253, at 7. Clinical validity asks whether the test results relate to the presence, absence, and/or risk of a disease or condition, while analytical validity only asks whether the test performed as intended. Jonathan R. Genzen, Regulation of Laboratory-Developed Tests, 152 Am. J. Clinical Pathology 122, 124 (2019) (noting that both clinical and analytical validity are important to ensure a test is safe but recognizing the risks of overregulation).

270 U.S. Food & Drug Admin., supra note 256, at 1; Office of Pub. Health Strategy and Analysis, U.S. Food & Drug Admin., The Public Health Evidence for FDA Oversight of Laboratory Developed Tests: 20 Case Studies (2015), http://www.nila-usa.org/images/nila/The%20Public%20Health%20Case%20for%20FDA%20Oversight%20of%20LDTs%20110915(2)_508ed%20(1).pdf [https://perma.cc/VU3Y-53R2].

271 VALID Act of 2020, S. 3404, 116th Cong. § 587(2)-(4) (2020).

272 VALID Act of 2020, S. 3404, 116th Cong. (2020). Mechanisms included in the act that borrow and expand on existing medical device regulation include premarket review, registration, labeling requirement, adverse event reporting, third-party review, user fees, mitigating measures (similar to special controls), and more. Id. The Act adds a grandfather clause for established LDTs fitting certain criteria. Id. § 587(c). One section also seeks to build upon the FDA’s recent strategic goals by supporting the establishment of collaborative communities and outlining measures for industry participation. Id. § 587S. The Act also diverges from existing medical device regulation by creating new pathways for LDTs in circumstances that warrant less regulatory burden and review. See VALID Act of 2020, S. 3404, 116th Cong. (2020). The technology certification process would allow a developer to use an approved technology certification for a representative test to develop tests within the scope of approval without having to submit for review each time. Id. § 587D. The Act also provides for prioritization of and flexibility for breakthrough LDTs. Id. § 587C. Perhaps most relevant, the VALID Act exempts LDTs from its regulatory burdens in public health emergency circumstances as long as the developer is seeking an EUA and validates the test prior to use. Id. § 587A(5).

273 See Evans & Clayton, supra note 99, at 99-100 (criticizing the VALID Act’s “one-size-fits-all” approach and pushing for substantial modifications). Given many of the exceptions and pathways carved out throughout the VALID Act, infra text accompanying note 277, one can hardly call the Act a “one-size-fits-all” approach. Suggested modifications, however, focus on lessening regulatory burdens for lower-risk and tried-and-true LDTs, an important concern. See Evans & Clayton, supra 99, at 100.

274 See Evans & Clayton, supra note 99, at 100.

275 Id. at 82-83. Evans and Clayton question the FDA’s authority to require EUAs for LDTs developed in high-complexity CLIA laboratories, even in times of crisis, because § 564 of the FDCA grants the FDA authority to grant EUAs for medical devices, but not clinical laboratory services. Id. at 80. This interpretation, of course, depends on the classification of an LDT as a service rather than a device. Evans and Clayton admit that “technically, LDTs do seem to fit the definition of an FDA-regulable medical device,” despite describing LDTs as a technical aid in an ultimate provision of a service. Id. at 88. Evans and Clayton note that the passage of the VALID Act would grant the FDA the necessary authority to regulate LDTs through EUAs and other methods, though are ultimately critical of its passage without substantial modifications. Id. at 86, 97.

276 Id. at 97; VALID Act of 2020, S. 3404, 116th Cong. § 6 (2020) (amending the FDA’s emergency use authorization authorities to explicitly include the term “in vitro clinical test”).

277 See, e.g., VITAL Act of 2020, S. 3512, 116th Cong. (2020).

278 See supra Part IV, Section C.

279 See Evans & Clayton, supra note 99, at 94 (citing Emergency Use Authorization: Emergency Use Authorization (EUA) Information, and List of All Current EUAs, U.S. Food & Drug Admin. (July 10, 2020), https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization [https://perma.cc/NQ49-PX2V]).

280 See supra Part IV, Section D.

281 See supra Part IV, Section A.

282 See supra Part III, Section A.

283 See supra notes 64-72 and accompanying text.

284 See U.S. Dep’t of Health and Human Servs., supra note 82, at 7-8.

285 The FDA did not seem to consider the risks posed by inaccurate serology tests when it decided to allow serology test kits on the market without any review whatsoever. See supra Part IV, Section C.

286 See supra Part IV, Section B. The FDA is reviewing ventilators through both EUA and 510(k) submissions. Ventilators that are essentially the same, or clones of, other functioning and safe ventilators approved for the market offer the only circumstance that the substantial equivalence standard logically works.

287 See supra Part IV, Section A.

288 The FDA admitted the need for greater oversight over respirators to protect the public health in discontinuing its initial guidance. See Ctr. for Devices and Radiological Health, supra note 132, at 9.

289 U.S. Dep’t of Health and Human Servs., supra note 82, at 8.

290 See Letter from Denise M. Hinton to Andre Hsiung, supra note 222; Letter from Denise M. Hinton to Louise M. Sigismondi, supra note 222; see also supra text accompanying notes 62-63.

291 Inst. of Med., supra note 62, at 15. This data does not include recalls initiated by the device developer, as the FDA database did not start including this data until January 2017.

292 See Pub. Cit., Substantially Unsafe: Medical Devices Pose Great Threat to Patients; Safeguards Must be Strengthened, Not Weakened 16-26 (2012), https://mkus3lurbh3lbztg254fzode-wpengine.netdna-ssl.com/wp-content/uploads/substantially-unsafe-medical-device-report.pdf [https://perma.cc/5Z8Z-VE77] (outlining four case studies of high profile recalls for dangerous devices cleared under the 510(k) process). A pad meant to shield healthy breast tissue from radiation exposure during breast cancer treatment left tungsten particles behind, causing long-term problems for periodic cancer monitoring and potentially cancer as well as severe disfigurement in some. Id. at 17. An infusion pump subject to numerous recalls was linked to four deaths and ten serious injuries. Id. at 20. A malfunctioning ligating clip caused six organ donors to die of internal bleeding and injured twelve others despite numerous recalls. Id. at 24-26. 93,000 patients received a faulty hip replacement promoted for younger patients, resulting in chronic problems with exercise, walking, and even standing. Id. at 26.

293 Ctr. for Devices and Radiological Health, supra note 161, at 7-8.

294 No ventilator EUAs have been revoked, and the low-performing respirators distributed in the month the FDA’s reversed policy was in effect do not seem to be linked to problems in medical settings.

295 Food & Drug Law Inst., supra note 9, at 68.

296 See id. at 234. Notably, however, IOM concluded in its report of the 510(k) process that it is unclear whether the 510(k) process facilitates or inhibits innovation. Inst. of Med., supra note 62, at 6.

297 See Josh Makower et al., supra note 13, at 24.

298 See supra Part IV, Section C.

299 See Inst. of Med., supra note 62, at 8.

300 See id., at 11.

301 See Inst. of Med., supra note 62, at 10.

302 See id.

303 See FDCA, § 564(e)(1)(A)(iii)-(iv), 21 U.S.C. § 360bbb-3(e)(1)(A)(iii)-(iv) (2018).

304 For example, the CDC testing debacle was a failure in premarket review that postmarket surveillance measures quickly detected. Replacing premarket review measures with postmarket review would have had the same unfortunate results.

305 CDC data on many of the respirators on the market due to the FDA’s guidance ultimately provided a form of postmarket surveillance that allowed the FDA to step in. The serology tests allowed on the market without review, on the other hand, were barely monitored. The FDA had such little data on the serology tests already on the market that it could not validate their accuracy during the congressional investigation.

306 Blum & Paradise, supra note 77, at 21.

307 See Evans & Clayton, supra note 99, at 79.

308 The most disastrous was the initial failure to conduct appropriate review of the first authorized diagnostic test, coupled with stalled LDT authorization. These events resulted in a disastrous delay in crucial identification and containment measures.

309 See What We Do, supra note 33.