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FDA Guidance Allows Limited Foreign Data To Approve Devices With Postmarket Caveat

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.

FDA says in a new guidance that limited but long-term clinical data collected outside of the U.S. (OUS) can be used to support PMAs on the condition sponsors gather postmarket data on U.S. patients to bolster their device's evidence profile.

The agency posted its final guidance "Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval" on April 8 to outline its policies on when postmarket studies can help fill in for gaps in premarket evidence. While the final guidance is almost identical to a draft guidance issued last year, it now specifically states sponsors can use data from studies conducted outside the U.S

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