FDA update 3rd August 2011

FDA to seek public comment on IOM recommendations

The FDA announced that it will open a public docket to begin receiving public comments on the Institute of Medicine’s (IOM) report on the 510(k) program, the most common pathway to market for lower-risk medical devices

FDA announced on Friday that it would not implement an Institute of Medicine committee's recommendation to scrap the 510(k) process, which allows marketing of Class II medical devices based on their substantial equivalence to already cleared devices.

The FDA turned to the Institute of Medicine (IOM), which appointed a committee to review the 510(k) process and answer two questions:

  • Does the current 510(k) process protect patients optimally and promote innovation in support of public health?
  • If not, what legislative, regulatory, or administrative changes are recommended to achieve the goals of the 510(k) process optimally?

The Report found that current 510 (k) processes is flawed based on its legislative foundation. Rather than continuing to modify the 35-year-old 510(k) process, the committee concludes that the FDA’s finite resources would be better invested in developing an integrated premarket and post market regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle. This new frame­work should:

  • be based on sound science;
  • be clear, predictable, straightforward, and fair;
  • be self-sustaining and self-improving;
  • facilitate innovation that improves public health by making medical devices available in a timely manner and ensuring their safety and effectiveness throughout their lifecycle;
  • use relevant and appropriate regulatory authorities and standards throughout the life cycle of devices to ensure safety and effectiveness; and
  • Be risk-based.

Current information is not adequate to design a new framework, and the FDA should begin to obtain the needed information. Once adequate information is available to design an appropriate medical-device regulatory framework, Congress should enact legislation to do so. A new regula­tory framework will benefit everyone patients, healthcare providers, the medical device industry, payers, and the FDA.

Conclusion: FDA believes that the 510(k) process should not be eliminated but FDA is open to additional proposals and approaches for continued improvement of device review programs.

PLEASE BE AWARE THAT THIS IS YOUR CHANCE TO MAKE YOUR THOUGHTS TO BE KNOWN: Written comments and suggestions may be submitted at any time for FDA  consideration to the Division of Dockets Management, Food and Drug Administration, 5630  Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. When submitting comments, refer to Docket No. FDA-2011-N-0556.

Or you can send your comments within 90 days at info@mdiconsultants.com and REF: public comment on IOM recommendations.