FDA Officials on COVID-19 Tests: Flexibility Never Meant We Would Allow Fraud

As the diagnostic community shifts its attention SARS-CoV-2 antibody testing, FDA flags a concerning number of COVID-19 antibody tests marketed under false and inappropriate claims. In response, the agency this week revised its March 16 policy, which has served as a regulatory roadmap for COVID-19 antibody tests, also known as serology tests. The revision comes about two weeks after FDA issued a warning to healthcare providers about the limitations of such tests. "In mid-March, it was critical for the FDA to provide regulatory flexibility for serology test developers, given the nature of this public health emergency and an understanding that the tests were not to be used as the sole basis for COVID-19 diagnosis, a fact that remains true today," Anand Shah, MD, deputy commissioner for medical and scientific affairs at FDA, and Jeff Shuren, MD, director of FDA's Center for Devices and Radiological Health said in a joint statement. "However, flexibility never meant we would allow fraud. We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety." According to Shah and Shuren's statement, some test developers have falsely claimed their serological tests are FDA approved or authorized. Others have falsely claimed that their tests can diagnose COVID-19 or that they ...
Source: MDDI - Category: Medical Devices Authors: Tags: COVID-19 Regulatory and Compliance Source Type: news