Proposed Changes to 510(K) Premarket Notification Program Will Impact How Medical Devices are Brought to Market

The Centers for Devices and Radiological Health (CDRH) has announced several recommendations for changing the 510(K) premarket notification process by which medical devices are approved and brought to market.  The recommendations are not official guidance yet as they will be open to public comment for 60 days. 

Recommendations of note include the creation of a new device class called “class IIb” devices which will require manufacturers to provide some form of clinical evidence to prove effectiveness. Companies with devices in this new class group would be required to put their devices in the hands of end users (physicians, nurses, etc) to determine if there are “design failures.” It is anticipated that only about 8 to 10 percent of the current devices on the market would fall into the class IIb, but in particular, infusion pumps are an example of the type of product that would be moved into the new group.

Other recommendations call for streamlining the premarket pathway for lower-risk novel devices by making major reforms in the implementation of the de novo process; enhancing communications between the agency and industry through new tools for announcing changes in premarket expectations; and enhancing science-based professional development for CDRH staff to keep them better informed of advancements in technology. 

For full details on the recommendations, see the story in MedCity News