- 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:
- The FDA sent letters to 25 firms that produce and issue “FDA registration certificates” to medical device companies (including manufacturers, distributors and sellers). In the letters, the FDA is requesting that firms cease producing and issuing such registration certificates. The registration certificates often have the look of an official government document and many display the FDA logo. The FDA does not issue any type of device establishment registration certificate. Registration and listing with FDA does not denote approval or clearance of the establishment or its devices. Some device manufacturers and distributors have used registration certificates to create the misimpression that the FDA has reviewed, approved, cleared or authorized their products.
- The FDA issued a guidance entitled, “COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers.” This guidance describes reporting and implementation recommendations to drug application holders about some common manufacturing changes to container closure system components consisting of glass vials and stoppers for approved sterile drug and biological products administered through injection or other non-oral routes. The FDA recognizes that during the COVID-19 public health emergency injectable products may need some changes to the primary packaging components (e.g., glass vials and stoppers) due to supply chain issues affecting their availability. This guidance is not being issued in response to problems with vials currently used in COVID-19 vaccines.
- The FDA alerted consumers, health care providers and other users of thermal imaging systems intended to measure human body temperature—also known as telethermographic systems, infrared thermographs, thermal cameras, and “fever cameras”—that improper use of the systems may provide inaccurate temperature readings due to a variety of factors. Additionally, the FDA issued several warning letters to certain firms offering unapproved, uncleared and unauthorized thermal imaging systems for sale. Warning Letters that have been issued by the FDA are published on the Warning Letters page, and COVID-19 related Warning Letters are published on FDA’s Fraudulent Coronavirus Disease 2019 (COVID-19) Products page.
- As part of the FDA’s effort to protect consumers, the agency issued two warning letters jointly with the Federal Trade Commission to SafaLab, Inc. and to B4B Corp. for selling an unapproved and misbranded product with fraudulent COVID-19 claims. The FDA also issued a warning letter to Mercola.com, LLC, for selling unapproved and misbranded products with fraudulent COVID-19 claims. Consumers concerned about COVID-19 should consult with their health care provider.
- Testing updates:
- As of today, 337 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 251 molecular tests and sample collection devices, 71 antibody tests and 15 antigen tests. There are 38 molecular authorizations that can be used with home-collected samples. There is one molecular prescription at-home test, two antigen prescription at-home test, and one over-the-counter (OTC) at-home 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.
- Alison Hunt