The U.S. FDA has taken the following actions as of May 14th in the ongoing response effort to the COVID-19 pandemic:
- The FDA issued an Emergency Use Authorization (EUA) for infusion pumps and infusion pump accessories that, among other things, meet certain safety, performance, and labeling criteria, in response to concerns relating to the insufficient supply and availability of the devices for use by healthcare providers in the continuous infusion of medications, total parenteral nutrition, and/or other fluids into patients during the COVID-19 pandemic. A manufacturer may request the addition of any eligible infusion pump and/or infusion pump accessory to Appendix A by submitting a request to CDRH-COVID19-InfusionPumps@fda.hhs.gov, as outlined in the EUA.
- The FDA issued an update to its guidance for pharmacy compounders that experience shortages of the personal protective equipment (PPE) they typically use to compound human drugs that are intended or expected to be sterile. In the update, FDA has clarified that drugs can be compounded under the policy in a segregated compounding area that is not in a cleanroom, when specific beyond-use dates are utilized.
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Testing updates:
- During the COVID-19 pandemic, the FDA has worked with more than 390 test developers who have already submitted or said they will be submitting EUA requests to the FDA for tests that detect the virus or antibodies to the virus.
- To date, the FDA has authorized 98 tests under EUAs, which include 85 molecular tests, 12 antibody tests, and 1 antigen test.