June 19, 2020: The U.S. Food and Drug Administration announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- The FDA issued an updated FDA COVID-19 Response At-A-Glance Summary that provides a quick look at facts, figures, and highlights of the agency’s response efforts.
- The FDA continues to take creative and flexible approaches to address access to critical medical products in response to COVID-19.
In partnership with academic researchers, non-traditional manufacturers, communities of makers, and individuals who are banding together to support and fill local and national needs, the FDA is actively engaged and is developing ways to support these groups seeking to help their communities.
Our goal is to help expand the availability of relevant products in ways that are consistent with the FDA’s public-health mission.
For example, the FDA is working in partnership with the National Institutes of Health (NIH), the Veterans Administration (VA), and America Makes to support non-traditional manufacturing approaches (e.g., 3D printing), to address device shortages including personal protective equipment (PPE).
Through this partnership, 3D-printable designs for COVID response are assessed by the VA, and the NIH posts them on its 3D Print Exchange. The FDA has, among other things, provided information on labeling and testing for face shields and face masks.
Today, the FDA web update documents how this partnership has contributed to the number of medical devices — including PPE — and parts available to support the COVID-19 response since its launch 10 weeks ago.
For example, 31 community-submitted designs passed the testing performed by VA clinics and were given clinically reviewed status.
In addition, this effort has so far matched more than 272,000 3D-printed face shields and more than 230,000 3D-printed face masks with health care providers and others in need.
The FDA has issued a temporary policy for face masks and respirators during the COVID-19 public-health emergency. - On Tuesday, June 23, 12:00‒1:00 pm ET, the FDA, along with the Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH) and the Occupational Safety and Health Administration (OSHA), will host the second webinar in the respirator webinar series on the topic of Importing Respirators for Health Care Personnel Use during COVID-19 Pandemic.
- The FDA updated its guidance, titled Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency, to facilitate notification regarding device manufacturing interruptions or discontinuances.
The FDA updated this guidance to include a list of device types and corresponding product codes that FDA recommends manufacturers consider in determining whether a notification under Section 506J of the FD&C Act is required during the COVID-19 pandemic.
The CARES Act, which added Section 506J to the FD&C Act, is an important step that advances FDA’s ability to prevent or mitigate potential medical device shortages during a public health emergency. - FDA issued a guidance that provides recommendations to pharmaceutical manufacturers on actions to take when an employee who has been directly involved in manufacturing drugs has a confirmed infection of COVID-19, symptoms of COVID-19, or has been exposed to an infected person. FDA’s recommendations are intended to help avoid negative effects on the safety and quality of drugs.
FDA expects drug manufacturers to evaluate existing manufacturing controls to prevent drug safety or quality issues related to contamination from SARS-CoV-2.
Drug manufacturers should also review CDC guidance regarding when employees may continue working following exposure or potential exposure to COVID-19 as well as procedures to minimize exposure and transmission in the workplace.
FDA is not aware of any drugs that have been contaminated with SARS-CoV-2 or of information indicating transmission of COVID-19 is associated with drugs. - The FDA issued a warning letter to one company for selling fraudulent COVID-19 products, as part of the agency’s effort to protect consumers. The warned company, Project 1600, Inc., offers cannabidiol (CBD) products for sale in the United States with misleading claims that the products can mitigate, prevent, treat, or cure COVID-19 in people.
There are currently no FDA-approved products to prevent or treat COVID-19. Consumers concerned about COVID-19 should consult with their health care provider. - The FDA issued a Letter to Clinical Laboratory Staff and Health Care Providers recommending that they stop using COVID-19 antibody tests that are listed on the FDA’s “removed” test list.
The “removed” test list includes tests in which significant clinical performance problems were identified that cannot be or have not been addressed by the commercial manufacturer in a timely manner, tests for which an Emergency Use Authorization request has not been submitted by a commercial manufacturer of a serology test within a reasonable period of time as outlined in the FDA’s guidance, and tests voluntarily withdrawn by the respective commercial manufacturers. - Testing updates:
- To date, the FDA has authorized 144 tests under EUAs; these include 122 molecular tests, 21 antibody tests, and 1 antigen test.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.
The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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