The U.S. Food and Drug Administration (FDA) issued a draft guidance titled “Safer Technologies Program for Medical Devices.” The guidance, released on September 18, 2019, expands upon the Safer Technologies Program which was originally described within the agency’s 2018 Medical Device and Safety Action Plan. The voluntary program 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.”¹
Through the Safer Technologies Program, FDA hopes to spur innovation towards safer medical devices. Features such as interactive and timely communications with FDA, review team support, senior management engagement, and prioritized review are expected to be part of the program. FDA believes that this interactive and expedited feedback model may reduce the total time for medical device development and authorization while still meeting the agency’s high standards for safety and effectiveness.
What types of devices are eligible for the Safer Technologies Program?
FDA states that “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.”¹
Comments on the draft guidance must be submitted by November 18, 2019. If your firm is developing a medical device intended to treat or diagnose non-life-threatening or reasonably reversible conditions that may be an eligible candidate for the new Safer Technologies Program, schedule a call with our experts today to discuss the regulatory pathway for your product.
Full draft guidance document: Safer Technologies Program for Medical Devices