Medical Devices

A nursing trade association group called for a complete end to reusing N95 and KN95 masks after FDA rolled back its emergency use authorizations (EUAs) for reuse of certain respirators due to safety concerns over the effectiveness of decontaminating them.

FDA chief Stephen Hahn has asked agency officials to look into whether some of the more flexible and novel approaches FDA has taken to respond to COVID-19, including allowing remote clinical trial visits, using real-world evidence to make certain regulatory decisions and streamlining lab test approvals, could be applied more broadly and on a more permanent basis.

FDA on Friday (May 29) took several steps to improve and ramp up use of the agency’s Orange Book in a bid to provide more timely and accurate information about generic drugs and spur generic drug competition.

FDA on Friday (May 29) called for stakeholders to provide input on how best to establish and sustain global rare disease clinical trial networks, which the agency says could help advance the third component of its Rare Disease Cures Accelerator platform that aims to improve clinical trials for rare diseases.

CMS is giving Medicare Administrative Contractors broad authority to set payment rates for COVID-19-related tests in their respective jurisdictions until the agency comes up with national Medicare payment rates.

FDA, the National Institutes of Health and the Department of Veterans Affairs are working with stakeholders to ensure 3D-printed swabs for COVID-19 testing can be widely manufactured and distributed with proper labeling and packaging, representatives from the three agencies told stakeholders during a virtual town hall on Friday (May 15).

European Union trade officials on Friday (May 15) will discuss EU-U.S. trade relations as the bloc’s trade commissioner, Phil Hogan, looks to refresh the trans-Atlantic relationship and address some irritants between the two on the path to economic recovery.

Senior administration officials on Monday (May 11) lauded FDA for it works authorizing new COVID-19 tests for the market, including the latest Emergency Use Authorization for the first COVID-19 antigen test, which one administration official described as a “major advance."

Sen. Elizabeth Warren (D-MA) urged the Trump administration Thursday (May 7) to increase production of vaccines, therapeutics, diagnostics and medical supplies by creating a federal agency to oversee public-private partnerships for the COVID-19 crisis.