On February 8, the FDA announced the launch of its new Medical Device Innovation Initiative. “This initiative has broad implications for how the FDA does business, and how we support and will continue to support important opportunities for innovation,” commented Dr. Margaret Hamburg, FDA Commissioner. “The pace of biomedical discovery continues to accelerate and the stakes have never been higher. By the end of the decade, a combination of trends, including international competition, will test America’s role as the Global leader in medical product innovation. And as a nation, we have important choices to make about how we move forward. As we do, the FDA is eager and prepared to help lead the way.” Hamburg added.
As part of this Medical Device Innovation Initiative, CDRH is considering a series of actions aimed at encouraging innovation, streamlining regulatory and scientific device evaluation, and expediting the delivery of innovative medical devices.
“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,” Shuren added.
To support this initiative, FDA plans to take action that will:
- Facilitate the development and regulatory evaluation of innovative medical devices by:
- Establishing the Innovation Pathway - a priority review program for pioneering medical devices; and
- Streamlining the de novo pathway.
- Strengthen the U.S. research infrastructure and promote high-quality regulatory science by:
- Establishing a voluntary third-party certification program for U.S. medical device test centers;
- Creating a publicly-available core curriculum for medical device development and assessment;
- Leveraging device experience and data collected outside the United States; and
- Advancing regulatory science for medical devices through prioritizing scientific research, establishing public-private partnerships, collaborating with other government agencies, and holding public workshops.
- Prepare for and respond to transformative innovative technologies and scientific breakthroughs by:
- Enhancing CDRH’s current horizon scanning process by adopting emerging horizon scanning methods, seeking public input to identify important and innovative medical device technologies as they arise, and periodically reporting its horizon scanning findings to the public; and
- Developing a Network (or Networks) of Experts to serve as a resource to assist in addressing scientific questions about emerging technologies with which our reviewers might not be immediately familiar.
Through the implementation of the Innovative Pathway premarket review process, FDA expects to conduct premarket reviews within 150 days, nearly half the time it currently takes the agency to review most premarket approval applications.
Medical Device Innovation Initiative White Paper:
FDA’s Medical Device Innovation Initiative Press Briefing:
CDRH Medical Device Innovation Initiative Home: