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Small Samples, Protocol Delays Mar FDA’s Use Of Postapproval Studies

Small sample sizes and delays in reaching protocol agreements are hindering FDA’s ability to use postapproval study data to track device performance, says a study in JAMA Internal Medicine.

FDA’s ability to track the performance of devices with postapproval studies is being compromised by the small sample sizes of these studies and delays in reaching protocol agreements, according to a Sept. 29 study.

The findings come as CDRH is increasing efforts to strengthen its postmarket surveillance system, but also as it is proposing...

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