Medical Devices

Over the weekend, FDA granted the first emergency use authorization (EUA) for a COVID-19 pooling test to Quest Diagnostics.

Industry experts predict the COVID-19 pandemic will be a catalyst to transition FDA toward conducting electronic-based medical product and facility assessments and facility inspections, and they say the agency needs to provide more clarity about what those inspections and assessments will look like moving forward.

The House Energy & Commerce Committee on Wednesday (July 15) passed to the House floor a bill that would make several policy changes to the Strategic National Stockpile and rethink how medical supplies in the SNS are managed, rotated, distributed and sold off to other government agencies.

A Massachusetts-based nurses union is pushing back on the Trump administration’s calls for health care workers on the frontlines of COVID-19 response to reuse personal protective equipment, including N95 respirators.

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.