September 18, 2019
“Because technology continues to advance, patients are benefitting from more innovative medical devices that can help improve their health and even save their lives. Safety and innovation are both important priorities for the agency. Improvements in each of these areas are expected to result in increased quality of life and health benefits for patients, while simultaneously providing a reasonable assurance of both safety and effectiveness,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “To promote these goals, today we’re issuing a draft guidance on a new voluntary pathway for certain medical devices and device-led combination products that do not otherwise meet the criteria for our Breakthrough Devices Program, but through innovative designs, have the potential to be significantly safer than currently available treatments or medical diagnostics. We believe the Safer Technologies Program for Medical Devices will help ensure that we’re giving patients timely access to safe, effective and high-quality medical devices by expediting their development, assessment and review, and by facilitating the generation of the robust evidence required to support product marketing authorizations. We will do this without changing our statutory standards, data requirements or quality of review.”
Today, the Food and Drug Administration issued draft guidance titled “Safer Technologies Program for Medical Devices,” a voluntary program that is expected to significantly improve the safety of available treatments or diagnostic devices for diseases or conditions that are less serious than those eligible for the agency’s Breakthrough Devices Program, but the use of which may be associated with serious or life-threatening risks.
The Safer Technologies Program, as described in our 2018 Medical Device and Safety Action Plan, aims to spur innovation towards safer medical devices and was modeled after the Breakthrough Devices Program. As agency resources permit, the Safer Technologies Program will include features such as interactive and timely communications with the FDA, review team support, senior management engagement and prioritized review. The FDA believes this interactive and expedited feedback may reduce the total time to develop a device and achieve marketing authorization, while still meeting the agency’s gold standard for safety and effectiveness. Advances in safety and innovation are both important priorities for the agency and improvements in these areas are expected to result in timely access to devices that can increase quality of life and health benefits for patients, while still providing reasonable assurances of both safety and effectiveness.
Devices and device-led combination products are eligible for this program if they are subject to review under a premarket approval application (PMA), De Novo classification request, or premarket notification (510(k)), and meet program eligibility factors as described in the guidance.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.