Medical Devices

FDA is considering updating its COVID-19 emergency use authorization test templates to ask antigen test developers how they plan to monitor for variant strains of the virus and to ensure that authorized tests can properly diagnose the new strains.

Nurses want FDA to completely end the reuse of N95 masks and say the agency’s latest action falls short, after FDA on Friday (Jan. 22) reissued an emergency use authorization that said the respirators should only be decontaminated and reused a maximum of four times.

President Joe Biden unveiled a national COVID-19 testing strategy that aims to dramatically increase the number of Americans tested as part of a new seven-pronged massive public health effort to mitigate the spread of COVID-19.

President-elect Joe Biden late Thursday (Jan. 14) unveiled a $1.9 trillion COVID-19 relief package that would pump $20 billion into a national vaccination program that results in 100 million vaccinations by the end of his first 100 days.

FDA is working to identify new mutant strains of COVID-19 and analyze how they respond to current diagnostic tests, agency chief Stephen Hahn told reporters on a Friday (Jan. 8) press briefing, just a few hours before FDA alerted health care providers it has identified three emergency authorized tests that could produce false negative results with a potential mutated variant of SARS-CoV-2.

Device manufacturers hope FDA will draft guidance laying out strict requirements for device servicers in 2021 after deregulation of third-party servicers was discussed in 2020 due to the COVID-19 public health emergency.

FDA forecasts plans in its latest unified agenda to propose seven new rules, none of which have been included in previous agendas.

FDA wants developers of at-home and over-the-counter COVID-19 tests to ensure their testing platforms are set up to report users’ results to public health officials, but one cybersecurity consultant warns that allowing software to share user information raises the potential for cybersecurity and data integrity issues.

The Trump administration on Thursday argued that an initiative aimed at facilitating trade in medical goods put forward by a group of members, including the European Union, was unnecessary because its advocates have not proven there is a problem to be solved.