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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The US FDA has published final guidance requiring firms to notify the agency about significant manufacturing interruptions of medical devices during a public health emergency, as well as a supplementary draft guidance that includes a list of specific devices that manufacturers must report to the agency when they are in short supply.
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This week, North Carolina health secretary Mandy Cohen was named the new head of the CDC; Congress debated PAHPA reauthorization; Cala Health launched a Parkinson’s Disease wearable; and IHealth.io was fined for consumer privacy violations.
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.