CDRH Industry: FDA Completes Review and Seeks Feedback on PMA Medical Device Product Codes

Today the FDA issued a notice in the Federal Register “Retrospective Review of Premarket Approval Application Devices; Striking the Balance Between Premarket and Postmarket Data Collection.”   This notice announces a set of Premarket Approval Application (PMA) medical device product codes that we have identified as candidates for reclassification, a reduction in premarket data collection through reliance on postmarket controls, and/or a shift in data collection from premarket to postmarket.

FDA’s Center for Devices and Radiological Health (CDRH) reviewed these product codes as a part of our 2014-2015 strategic priorities. Our goal was to determine whether or not, based on our current understanding of the technology, we could reduce premarket data collection by relying on postmarket controls, shift some premarket data collection to postmarket, or to pursue reclassification.

On April 29, 2015, we announced the first set of product codes identified, and requested public comment. We are considering the comments received and prioritizing any changes based on public health impact and CDRH resources. 

With today’s notice, we have completed our review of all product codes, and are requesting comments on the second and final set of product codes identified as candidates for reclassification, a reduction in premarket data collection through reliance on postmarket controls, or a shift in premarket data collection to postmarket.  Additional information, including the results of the analysis and the results of the first set of product codes are posted online.

Detailed information can be found in the federal register notice by searching for docket number FDA-2016-283 on www.regulations.gov, on August 8, 2016 when the notice officially publishes.

You may submit comments to the docket until October 7, 2016.

Thank you,

Food and Drug Administration
Center for Devices and Radiological Health