FDA issues guidance on removed COVID-19 antibody tests; reporting potential medical device shortages

Clinical laboratories and health care providers should stop using any antibody tests on the Food and Drug Administration’s “removed” test list, evaluate prior results from the test and whether to retest the patient using an FDA-authorized test, the agency said Friday. FDA advises labs and providers to report any issues using COVID-19 tests.

In other news, FDA Friday issued guidance implementing the Coronavirus Aid, Relief, and Economic Security Act requirement that medical device makers report supply disruptions during the COVID-19 emergency to prevent shortages.