FDA update – February 11, 2011

FDA launches Medical Device Innovation Initiative

The US Food and Drug Administration (FDA) proposed a new “innovation pathway” initiative on February 08, 2011 to expedite review of innovative medical devices. The purpose of this initiative is to get revolutionary treatments to patients as soon as possible. The first medical device submitted by the Defense Advanced Research Projects Agency (DARPA) under this program is a brain-controlled, upper-extremity prosthetic which is designed to restore near-natural arm, hand and finger function to patients suffering from spinal cord injury, stroke or amputation. The arm system uses a microchip implanted on the surface of the brain to record neuronal activity and decode the signals to actuate motor neurons that control the prosthesis. DARPA and the FDA have signed a Memorandum of Understanding addressing both the development and review of this project.

This Innovation Initiative will encourage discovery of cutting-edge technologies among medical device manufacturers. Proposed actions include:

  • Establishing a voluntary, third-party certification program for U.S. medical device test centers designed to promote rapid improvements to new technologies during a product’s development and clinical testing stages;
  • Creating a publicly-available core curriculum for medical device development and testing to train the next generation of innovators; and
  • Using more device experience and data collected outside the United States.

This innovation Pathway Program has following features:

  • Products would have to be truly pioneering technologies with the potential of revolutionizing patient care or health care delivery;
  • Selected products would receive an Innovation Pathway memorandum from CDRH containing a proposed roadmap and timeline for device development, clinical assessment and regulatory review; and
  • Products would be assigned a case manager, their important scientific issues would be identified and addressed earlier in the development process, and they might be able to qualify for flexible clinical trial protocols.

Due to this initiative a review time will reduce to a half for such products. However, safety and effectiveness of such products will be carefully considered during such expedite review. Applications would be reviewed by the Center Science Council, a new oversight body currently being developed within Center for Devices and Radiological Health (CDRH). FDA will hold a public meeting on the initiative in March and will accept comments through April 11, 2011.

For more information on this issue you can go to the following link: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm242629.htm  or contact mdi at info@mdiconsultants.com