FDA Issues Guidance to Increase Access to Medical Devices

The Safer Technologies Program for Medical Devices aims to expedite the development and review of eligible medical devices.

The U.S. Food and Drug Administration (FDA) today issued a draft guidance to expedite the development of safe and effective medical devices to increase patient access.

The guidance, titled “Safer Technologies Program for Medical Devices,” is a voluntary program that aims to improve the safety of available devices for diseases or conditions that are less serious than those eligible for the agency’s Breakthrough Devices, but could be associated with serious or life-threatening risks.

The program will include interactive and timely communication with the FDA, review team support, senior management engagement and prioritized review, the agency announced.

“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,” said Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.

For patients to continue benefitting from innovative medical devices, technologies and products that do not meet criteria for the FDA’s Breakthrough Devices Program — but have the potential to be significantly safer than currently available treatments or diagnostics — could be considered for the new program, Shuren said.

Examples of these devices include those that treat or diagnose non-life threatening or reasonably reversible conditions.

Products are eligible for the program if they are subject to review under a premarket approval application, de novo classification request or premarket notification.

The program further enforces FDA's priority to evaluate emerging tech.

Individuals can submit comments on the draft guidance by Nov. 18.

Get the best insights in digital health directly to your inbox.

Related

FDA Official: Modernization Plan Coming Soon

How Will New FDA Guidelines Affect Digital Health?

FDA Announces New Device Guidance, Enhanced Patient Input Program