Medical Devices

The Democratic leaders of key congressional health committees say recent Trump administration guidance that says insurers are not required to cover COVID-19 testing for surveillance or return to work screenings clashes with congressional intent.

HHS expects that an additional 5 million COVID-19 point-of-care tests will come onto the market this month, which should bring the total number of available point-of-care tests to 10 million, Assistant Secretary for Health Brett Giroir told reporters on Wednesday (July 1).

FDA chief Stephen Hahn said the COVID-19 pandemic has shed light on the need for increased use of real-world evidence to help regulators make decisions in real time, and he asked Congress to provide more support for advancing generation of RWE.

Medical device manufacturers are urging FDA to release guidance detailing the agency’s expectations for products released under emergency use authorizations (EUAs) and emergency discretion guidances once the COVID-19 public health emergency comes to a close and the temporary approvals are suspended.

Stakeholders are concerned that China’s list of COVID-19 tests that are authorized for export is preventing myriad coronavirus diagnostic and serology tests from being sent to the United States, even though those tests are authorized for distribution in America.

The Information Technology & Innovation Foundation, a non-profit think tank that focuses on public policy and innovation, is concerned the Trump administration’s latest push to “Buy American” could have unintended consequences on the medical product supply chain, despite the administration’s assertions that it could help ease American reliance on foreign drug production.

House lawmakers and public health experts on Tuesday (June 9) called for FDA to quickly remove unauthorized COVID-19 serology tests from the market pending agency review to prevent so-called junk tests from being marketed and sold to doctors and consumers.

Third-party medical device servicers want Congress, FDA and CMS to ensure that, post-COVID-19, servicers will still be able to obtain critical device servicing materials, including equipment manuals and training, access to which has increased during the pandemic thanks to collaboration between servicers and device makers.

FDA on Friday (May 29) published a voluntary Emergency Use Authorization template for COVID-19 at-home sample collection kits.