FDA Announces Availability of “Medical Device Innovation Initiative” Report for Public Comment

Feb 10, 2011   

The U.S. Food and Drug Administrations (FDA) announced in the Federal Register on February 9, 2011 that its report entitled “Medical Device Innovation Initiative” is available for public comment. This report proposes potential actions to be taken by the FDAs Center for Devices and Radiological Health (CDRH) to facility the development, assessment, and regulator review of innovative medical devices.

On February 8, 2011, the FDA proposed its “Innovation Pathway,” which is a priority review program for “new, breakthrough medical devices.” The agency announced that the first submission to the program will be a “brain-controlled, upper-extremity prosthetic.” The FDA is seeking further public comment before the Pathway will be used more broadly.

CDRH announced 25 actions it will take this year to improve its 510(k) program, the FDAs premarket review process for certain medical devices. CDRH has expressed its desire to “increase its use of emerging science to foster innovation and improve the predictability, consistency, and transparency of its decision making.” Click here to read the FDAs “510K) and Science Report Recommendations: Summary and Overview of Comments and Next Steps.”

The report on medical device innovation outlines CDRH actions that may be put into place to accelerate the agencys evaluation of innovative devices. Some of these actions include:

  • Facilitate the development and regulatory evaluation of innovative medical devices;
  • Strengthen the U.S. research infrastructure and promote high-quality regulatory science; and
  • Prepare for and respond to transformative innovative technologies and scientific breakthroughs.

The Federal Register notice announcing the availability of the report for public comment acknowledges that the U.S is the global leader in innovative medical devices. The notice states that millions of Americans benefit from innovative medical devices that “reduce suffering, treat previously untreatable conditions, extend lives, and improve public health.” CDRH has stated that because of the need for these innovative devices, the office has committed itself to assuring that these new technologies and products are available on a timely basis while still retaining their safety and efficacy.

The FDA has been criticized by the medical device industry for its 510(k) process. The industry has been vocal in its views that the review process is much too slow and much too inconsistent. Click here to read an article in the New York Times on domestic medical device firms sending business overseas.

CDRH is seeking public comment on the report and the proposals outlined therein. The FDA will be holding a public meeting to garner stakeholder feedback at its White Oak, Maryland campus on March 15, 2011.

The FDA news release on its Innovation Initiative can be found here.