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.


The FDA is on a roll, releasing yet another draft guidance on medical device regulations this week, this time providing an overview of the postmarket surveillance program and procedural information on how companies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

The new guidance details what types of devices may qualify for postmarket surveillance, including class II or III devices intended to be implanted in the body for more than year and those intended to be life-sustaining or life-supporting.

The FDA's new recommendations that the 36 month cut-off for surveillance programs be extended for devices with a big presence in pediatrics to observe impact on growth and development.

The public comment period on the "Postmarket Surveillance Under Section 522 of the Federal Food, Drug and Cosmetic Act" guidance document will remain open for the next three months.