FDA Holds Only Public Meeting On MDUFA V Package
Stakeholders expressed support for the proposal at the Tuesday meeting – along with some reservations.
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The user fee package was among several health-related bills that the subcommittee took up on Wednesday.
The US Government Accountability Office reviewed how the FDA reviewed and monitored COVID-19 tests during the pandemic and found room for improvement. One particular concern was the lack of a straightforward policy on when enforcement discretion would be used.
The tests are being moved to class II, special controls, after the agency determined that would be enough to ensure device safety and efficacy.