Medical Devices

FDA will not pursue enforcement action against the distribution and use for medical purposes of “improvised” face masks that have not complied with certain device regulatory requirements, the agency announced in a temporary policy released Thursday (March 26).

A draft Senate COVID-19 stimulus compromise floated Tuesday (March 24) maintains multiple provisions that would expand requirements for drug makers to report product shortages, give FDA authority to require device makers report shortages and potential supply disruptions, and protect manufacturers of respiratory masks from lawsuits.

FDA on Monday (March 23) announced new procedures that will allow the agency to issue COVID-19-related guidance documents as fast as possible.

Senate Republicans attempted to remove language that would exempt drug shortage reports from Freedom of Information Act (FOIA) disclosures while adding in confidentiality language in their phase three COVID-19 package unveiled Sunday (March 22).

The American Clinical Laboratory Association is pressing Congress to provide surge capacity funding and other resources to labs conducting COVID-19 testing. In a letter sent to Senate and House leaders Thursday (March 19), ACLA calls for $5 billion for labs, and requests Congress clarify that labs can qualify for loans and other resources under the Defense Production Act.

FDA has postponed all routine domestic facility inspections in order to protect the health and well-being of agency staff and to address industry’s concern over visitors, FDA announced Wednesday (March 18), coming as the Trump administration advises against unnecessary travel due to the nationwide spread of COVID-19.

The Trump administration took new steps Friday (March 13) to speed up coronavirus testing: HHS Secretary Alex Azar tapped former acting FDA chief Brett Giroir to coordinate diagnostic testing efforts by the Centers for Disease Control and Prevention (CDC), FDA and public and private laboratories across the country; and FDA decided to let the New York State Department of Health (NYSDOH) use a third-party reviewer to authorize diagnostic tests and granted Roche Molecular Systems the agency’s third Emergency Use Authorization for a laboratory developed test.

Republican senators and administration officials are pushing for a vote this week on bipartisan legislation that would shield certain manufacturers and distributors of masks from lawsuits during the coronavirus outbreak.

By next week, public health labs and hospitals should have enough COVID-19 diagnostic test kits to conduct up to 4 million tests, HHS Secretary Alex Azar told reporters Friday (March 6), shortly after President Donald Trump signed into law an emergency coronavirus supplemental funding bill that gives $61 million to FDA for medical product shortage response efforts and that waives certain Medicare telehealth restrictions during the COVID-19 public health emergency.