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More Postmarket Data Collection Could Allow Transferal from Class III to Class II

August 16, 2016

The FDA is announcing a new set of product codes that it is considering reclassifying as lower risk and is seeking industry comment.

The reclassification effort is connected with the Center for Devices and Radiological Health’s strategic priorities to reduce reliance on premarket data and rely more on postmarket data when appropriate to increase patient access to needed devices.

The agency acknowledges that it is a balancing act to determine how much premarket data is necessary to assure safety and efficacy of devices in the premarket setting. — Tamra Sami

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