Coronavirus (COVID-19) Update: May 28, 2021

FDA News Release

• For Immediate Release: May 28, 2021

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

• This week, FDA released the Medical Countermeasures Initiative (MCMi) Program Update report which showcases FDA's work each year to prepare for all types of public health emergencies, including COVID-19. This report, covering fiscal year 2020, includes a snapshot of FDA's COVID-19 response during the reporting period.
• As part of the FDA’s effort to protect consumers, on May 27, the agency issued a warning letter jointly with the Federal Trade Commission to Oclo Nanotechnology for selling unapproved chlorine dioxide products with unproven COVID-19 claims. FDA continues to warn consumers not to drink chlorine dioxide products including “OCLO 3000.” Drinking any chlorine dioxide product can cause nausea, vomiting, diarrhea and symptoms of severe dehydration. Consumers concerned about COVID-19 should consult with their health care provider.
• On May 27, 2021, the FDA issued an Update: FDA Recommends Transition from Use of Non-NIOSH-Approved and Decontaminated Disposable Respirators - Letter to Health Care Personnel and Facilities. The FDA is recommending health care personnel and facilities transition away from crisis capacity conservation strategies, such as using non-NIOSH-approved disposable respirators, including imported respirators such as KN95s. This recommendation is a follow-up to the April 9, 2021, letter in which the FDA recommended a transition away from decontamination or bioburden-reduction systems for cleaning and disinfecting disposable respirators which were being reused by health care personnel.
• Testing updates:
  • As of today, 379 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 274 molecular tests and sample collection devices, 80 antibody and other immune response tests and 25 antigen tests. There are 51 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one molecular prescription at-home test, two antigen prescription at-home tests, four antigen over-the-counter (OTC) at-home tests and two molecular OTC at-home tests.
  • The FDA has authorized nine antigen tests and four molecular tests for serial screening programs. The FDA has also authorized 516 revisions to EUA authorizations.