FDA launches medical device innovation initiative

The U.S. Food and Drug Administration (FDA) is hoping to streamline the development and commercialization of new medical devices through a new initiative dubbed Innovation Pathway, a priority review program for new, breakthrough medical devices.

The newly proposed program, announced February 8, is part of a broader effort under way 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, according to the FDA. Proposed actions include the following:

• 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
• Using more device experience and data collected outside the U.S.

In addition, CDRH intends to monitor 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.

Other details of the proposed Innovation Pathway program include:

• Products would have to be truly pioneering technologies with the potential of revolutionizing patient care or healthcare delivery.
• Selected products would receive an Innovation Pathway memorandum from CDRH containing a proposed road map and timeline for device development, clinical assessment, and regulatory review.
• 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 in Silver Spring, MD.