If You're as Disappointed with the 510(k) Process as Everyone Else Who Manufactures Medical Devices, Here Is Your Chance to Actually Influence the Process

On Tuesday August 31, 2010, CDRH will host a live webinar to discuss the details of both reports and respond to any questions and concerns raised by the medical device Community. Click:


The FDA is now seeking additional public comments and input on the reports, especially on implementation feasibility and on potential alternatives.  

Before You Can Help Yourself, You Must Know the Subject Well

The 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act, formally established jurisdiction by the FDA over medical devices, requiring premarket review and approval by the FDA by means of a 510(k) submission prior to any marketing of new products. Such review is for the purposes of making available to consumers devices that are safe and effective, and fostering innovation in the medical device industry. “The 510(k) process was originally intended to ensure economic parity between post-enactment and pre-enactment devices.” Riegel v. Medtronic, 451 F.3d 104 (2d Cir. 2006).

Thirty-three years after the Amendments and the birth of the 510(k), in September 2009, CDRH convened an internal 510(k) Working Group that began a comprehensive assessment of the 510(k) process, being charged with evaluating the 510(k) program and exploring actions CDRH could take to strengthen the program and to improve the constancy of its decision making, with a principal focus on actions the Center could take in the short term under its existing statutory authority. Another and independent assessment by the Institute of Medicine is expected to conclude in the summer of 2011. (Another recent CDRH Report is entitled “Volume II: Task Force Utilization of Science in Regulatory Decision Making Preliminary Report and Recommendations.”)

Two open meetings earlier in 2010, plus comments entered into the dockets of each group, provided significant input for the Reports.

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