FDA Encourages Voluntary Device Shortage Reporting After PHE End
The FDA updated its policies regarding 506J notifications for device manufacturers at the end of the public health emergency.
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‘Wait-and-See Time’: Panel Predicts Limited Congressional Action On Devices This Year
An expert panel at the FDLI annual meeting expects the US Congress to want to see more results from recent legislation on devices before it moves ahead with further FDA reform. Though, pandemic-related measures remain a priority.
COVID-19 EUAs To Stay Active After Public Health Emergency Ends
Authorizations in place for diagnostics, personal protective equipment, and other products cleared for emergency use during the pandemic will remain in place until the potential for an outbreak no longer exists or products receive traditional clearances, according to a Federal Register notice issued by HHS this week.
So The Public Health Emergency Is Over. Now What?
In January, US President Joe Biden announced that the COVID-19 public health emergency will expire in May. Dr. David Feldman, chief medical officer at The Doctors Company, spoke to Medtech Insight about what the official end of the emergency means for average Americans.