- For Immediate Release:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- Today, the FDA issued a guidance, “Enforcement Policy for the Quality Standards of the Mammography Quality Standards Act During the COVID-19 Public Health Emergency.” This guidance provides the FDA’s enforcement policy regarding certain requirements for mammography facilities and general considerations in response to common scenarios faced by mammography facilities as a result of the COVID-19 public health emergency.
- On Dec. 3, the agency issued an Emergency Use Authorization (EUA) for the Lumin LM3000 Bioburden Reduction UV System, the first ultraviolet-C (UV-C) light based bioburden reduction system for emergency use in bioburden reduction of certain N95 respirators when there are insufficient supplies of filtering facepiece respirators resulting from the COVID-19 pandemic. The system, manufactured by 3B Medical Inc., is a Tier 3 system intended for bioburden reduction (or reduction of microorganisms) of 3M Model 1860 N95 respirators only, and only for single-user reuse, as a supplement to the Centers for Disease Control and Prevention (CDC) reuse recommendations. Tier 3 bioburden reduction systems are intended to be used in addition to and not in lieu of CDC reuse recommendations. In evaluating the EUA request, the FDA reviewed available scientific evidence, including scientific literature, performance testing, and other information related to bioburden reduction and the use and reuse of filtering facepiece respirators as described in the FDA guidance.
- The FDA has added content to the question-and-answer appendix in its guidance titled, “Conduct of Clinical Trials of Medical Products During COVID-19 Public Health Emergency.” The updated guidance includes a new question and answer regarding considerations for disposing unused investigational drug product when a study participant cannot return it to the study site. The guidance addresses considerations for using alternative procedures for the disposition of the investigational product provided that such procedures do not expose humans to risks from the drug.
- PrecisionFDA has launched the COVID-19 Precision Immunology App-a-thon. The agency encourages the scientific and analytics community to develop innovative applications to explore the relationship between personalized immune repertoires and COVID-19 disease variables and associated factors. The challenge is open now through January 29, 2021.
- Testing updates:
- As of Dec. 1, 295 tests are authorized by FDA under EUAs; these include 227 molecular tests, 61 antibody tests, and 7 antigen tests.
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.
- Jane Hubbard