The US Food and Drug Administration is working to facilitate emergency use authorization for coronavirus (COVID-19) medical devices, including diagnostic tests and respirators, while also working with the Federal Trade Commission to crack down on unapproved products.
The secretary of the US Department of Health and Human Services (HHS) determined on February 4 that the COVID-19 outbreak was a public health emergency. This determination allows the US Food and Drug Administration (FDA) to use its emergency use authorization (EUA) authority for medical devices intended to diagnose and prevent COVID-19 and SARS-CoV-2, the virus that causes COVID-19. FDA’s EUA process is an expedited premarket pathway to authorize medical products for emergency use, and FDA has already issued several documents to promote EUA submissions for COVID-19 devices.
In addition, FDA is working to track device supply issues resulting from the outbreak, and has coordinated with the Federal Trade Commission (FTC) to issue warning letters to companies marketing potentially violative therapeutic products for COVID-19. The COVID-19 outbreak also has impacted FDA’s own operations, and FDA announced its intent to postpone routine foreign inspections until April.
This LawFlash summarizes these key FDA developments.
COVID-19 Diagnostic Test Development
FDA’s EUA process allows for expedited review of medical products for emergency use during a public health emergency when there are insufficient alternative products. FDA evaluates EUA requests using a more flexible standard of review (i.e., a determination that the device may be effective and the known and potential benefits outweigh the known and potential risks).
To date, FDA has issued EUAs for two COVID-19 diagnostic tests, but test availability and testing capacity in the United States remain limited. To facilitate more rapid test development, FDA has issued multiple documents for clinical laboratories developing tests in-house, as well as test kit manufacturers, as described below.
Laboratory Developed Tests
To promote the development and implementation of COVID-19 tests by laboratories (including independent and hospital laboratories), FDA issued on February 29 a new guidance document, Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency. Under this guidance, FDA will permit a laboratory to perform COVID-19 testing if all of the following criteria are met:
- The test is developed by and will be used in a laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity testing.
- The laboratory completes validation of the diagnostic test.
- The laboratory notifies FDA once the test is validated.
- The laboratory submits an EUA request for its test to FDA within 15 days of completing the validation.
- The laboratory confirms the first five positive and first five negative clinical specimens using an EUA-authorized assay.
The guidance also provides recommendations on testing to ensure analytical and clinical validity. In addition, FDA developed an “accelerated” EUA template for laboratories to use for their COVID-19 tests (available on the FDA website) to facilitate the preparation and submission of EUAs.
COVID-19 Test Kits
Although FDA’s February 29 guidance is limited to tests developed by CLIA high-complexity labs, FDA has also taken steps to promote the development of diagnostic test kits by device manufacturers, which can be distributed and used more broadly. Specifically, FDA issued on March 6 a separate EUA template for test kit manufacturers (available on the FDA website) to provide guidance on the recommended EUA submission format and recommended testing and information to support a submission for a COVID-19 test kit. FDA also published on March 6 an FAQ on Diagnostic Testing for SARS-CoV-2, which it is updating on an ongoing basis.
Personal Protective Equipment
On March 2, FDA issued a letter of authorization for certain N95 respirators approved by the National Institute for Occupational Safety and Health (NIOSH). FDA states in this letter that it will authorize emergency use of “eligible” NIOSH-approved respirators, including those that have passed their shelf life or expiration date, upon the submission of a request from the Centers for Disease Control and Prevention (CDC), the device manufacturer, or a strategic stockpiler. The respirators would be authorized for use in healthcare settings by healthcare personnel (HCP) “to prevent wearer exposure to pathogenic biological airborne particulates during [respirator] shortages resulting from the COVID-10 outbreak.”
The letter further describes the information that should be included in any such request and the relevant conditions of authorization. Appendix A to the letter sets forth FDA’s list of “eligible” NIOSH-approved respirators, and Appendix B sets forth the list of respirators authorized by FDA for emergency use in healthcare settings by HCP per the process described above (both appendices available on the FDA website).
FDA and FTC Warning Letters
As FDA encourages the development and authorization of COVID-19 devices through its EUA processes, FDA also is working with the FTC to crack down on the marketing of unapproved products. On March 9, FDA and FTC announced that they had issued warning letters to multiple companies for the promotion of products to cure, treat, or prevent COVID-19. These were the first enforcement letters issued by FDA for COVID-19 claims.
FDA Concerns for the Medical Device Supply Chain
FDA is closely tracking potential supply chain disruptions for medical devices resulting from the impact of the COVID-19 outbreak on device manufacturing facilities located in China. Although drug manufacturers are required to report drug shortages to FDA, there is no corresponding reporting requirement for medical device manufacturers. FDA is, nonetheless, encouraging device manufacturers to report any such issues and has established an email address specifically for reporting device shortages.
In a press release on COVID-19 supply chain issues, FDA Commissioner Dr. Stephen M. Hahn described mandatory device reporting requirements that the administration had proposed to Congress, including requirements that “firms notify the agency of an anticipated meaningful interruption in the supply of an essential device” and that “all manufacturers of devices determined to be essential . . . periodically provide the FDA with information about the manufacturing capacity of the essential devices they manufacture.”
COVID-19 Impact on Foreign FDA Inspections
The COVID-19 outbreak has also impacted FDA’s own operations. On March 10, FDA issued a press release stating its intent to postpone routine foreign inspections until April, which can include preapproval inspections for Humanitarian Device Exemption (HDE) and Premarket Approval (PMA) submissions. FDA stated, however, that “[i]nspections outside the U.S. deemed mission-critical will still be considered on a case-by-case basis.”
For-cause foreign inspections will continue to be staffed. The March 10 announcement does not extend to domestic inspections.