FDA launches Medical Device Innovation Initiative
DARPA-funded prosthetic is first test case
The U.S. Food and Drug Administration proposed the Innovation Pathway, a priority review program for new, breakthrough medical devices and announced the first submission: a brain-controlled, upper-extremity prosthetic that will serve as a pilot for the program. The FDA also announced plans to seek further public comment before the Pathway can be used more broadly.
The new proposed Innovation Pathway program for pioneering medical devices, highlighted in a report published on the FDA's website today, is part of a broader effort underway in the FDA's Center for Devices and Radiological Health (CDRH) designed to encourage cutting-edge technologies among medical device manufacturers.
The initiative will also seek to strengthen the nation's research infrastructure for developing breakthrough technologies and advancing quality regulatory science. 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.
In addition, CDRH intends to engage in formal horizon scanning - monitoring medical literature and scientific funding in a systematic way to predict where technology is heading. CDRH will include public input in this process to prepare for and respond to transformative innovative technologies and scientific breakthroughs.
"Each year, millions of American patients benefit from innovative medical devices that reduce suffering and treat previously untreatable conditions," said CDRH Director Jeffrey Shuren, M.D., J.D. "CDRH's Innovation Initiative will help accelerate the development of and patient access to innovative medical devices, which often fulfill unmet public health needs."
The FDA has accepted its first submission from the Defense Advanced Research Projects Agency (DARPA) to review a brain-controlled, upper-extremity prosthetic 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.
The proposed Innovation Pathway program includes the 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.
Applications would be reviewed by the Center Science Council, a new oversight body currently being developed within CDRH comprised of senior managers and experienced scientists, who would facilitate this device development and evaluation process. Enrollment in the Innovation Pathway program would not change the scientific or regulatory standards that CDRH would use to evaluate device submissions and determine their appropriateness for marketing.
Because of the transformative nature of the devices that would be eligible for this pathway, CDRH expects them to generally be approval pathways intended for either high risk or novel products.
The FDA could conduct premarket reviews of products in the Innovation Pathway within 150 days, nearly half the time it currently takes the FDA to review most premarket approval applications.
CDRH has set up a public docket to solicit public comment on the Innovation Initiative and will host a public meeting on the topic on March 15, 2011 at the Center's White Oak campus.
For more information:
- CDRH Medical Device Innovation Initiative at http://www.fda.gov/deviceinnovation2