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 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.
To better understand when it would be appropriate to shift premarket data collection to the postmarket setting, the agency released guidance in April 2015 that outlined how it would consider postmarket data to support premarket approvals via en expedited access pathway.
The agency also conducted a retrospective analysis of all PMA product codes with active PMAs prior to 2010 to better understand if premarket data collection could be shifted to the postmarket setting.
The study analyzed postmarket performance data, technology and performance considerations for each procode to determine the current benefit-risk profile.
Postmarket performance data analyzed included PMA annual reports, literature reviews, total product lifecycle reports, medical device reporting, market penetration and recalls.
The study recommends certain devices be reclassified from Class III to Class II to allow for reduced premarket data collection. Comments are due Oct. 7.
See the list of recommended products and procodes here: www.fdanews.com/08-10-16-FDAPMAanalysis.pdf, and read the FDA notice here: . — Tamra Sami