FDA releases new guidance on postmarket surveillance

August 16, 2011 by MassDevice staff

The FDA unveiled its latest guidance providing an overview of the postmarket surveillance program for medical devices and extending the surveillance period for pediatric devices.

FDA

The FDA is on a roll, releasing yet another draft guidance on medical device regulations this week, this time providing an overview of the postmarket surveillance program and procedural information on how companies should comply.

The new guidance highlights postmarket programs for devices with a big footprint in pediatrics, makes recommendations for submission protocol for postmarket studies, outlines study status procedures and updates the postmarket surveillance program in light of its transfer to the division of epidemiology's office of surveillance and biometrics.

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