FDA Releases Preliminary Evaluations on 510(k) Process

The FDA released its preliminary report on the 510(k) review process, and provided recommendations on what it believes can be done to improve it. The detailed report included an executive summary that provided an overview of the recommendations which can be viewed here.

Mark Leahey, President and CEO of MDMA, stated that “CDRH’s preliminary report and evaluations mark an important first step in discussing improvements to the 510(k) process so that patients and providers have access to safe and effective medical devices. At the end of the day, everyone benefits when a reasonable and predictable 510(k) process is in place.”

There is a 60 day comment period for the report, and MDMA staff continues to review the detailed report and recommendations. MDMA will be providing comments, and working with our members to ensure that all of their concerns and thoughts on these recommendations are included.