FDA Guidance Allows Limited Foreign Data To Approve Devices With Postmarket Caveat
This article was originally published in The Gray Sheet
As FDA puts more emphasis on postmarket data collection in its PMA approval process, the agency has released a final guidance on balancing premarket and postmarket studies.
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CDRH says it exceeded its goal to retrospectively review half of all pre-2010 PMA device types. So far, 21 categories have been slated as candidates for downclassification and another 21 may be tagged for shifting some data requirements to the postmarket.
During her final public appearance at the National Press Club, outgoing FDA Commissioner Margaret Hamburg defended her tenure and said she was leaving a stronger FDA than the one she inherited. Asked about the agency's device regulatory process, she said she didn't know if FDA or Europe had struck the right balance but said more work needs to be done.
A planning board created to develop a framework for a new U.S. medical device surveillance system has proposed a seven year plan on how to get the system up and running, which will include creating incentive systems for stakeholders as well as reducing the burden of recording and managing device data.