AdvaMed Nov. 15 released comments and recommendations for the FDA that would allow the medical device industry to better understand the agency’s intentions behind the program, called the Safer Technologies Program for Medical Devices. It would speed up the approval process by providing eligible devices prioritized review and interactive communication with review teams that evaluate devices.
The STeP program is intended for devices that are expected to “significantly” improve the safety of currently available treatments but aren’t eligible for the FDA’s Breakthrough Devices Program, which is limited to devices designed to treat life-threatening or irreversibly debilitating diseases.
AdvaMed said that while it supports the FDA’s efforts to speed up access to medical devices, the draft guidance for the program it released Sept. 19 isn’t clear on what kind of devices would be eligible. Specifically, AdvaMed said the FDA needs to define what it means by “significantly” improve safety.
AdvaMed also asked the FDA to provide examples of devices that both meet and don’t meet standards for the program. It also asked the FDA to allow device reviewers to give “informal high-level feedback” on the development of devices to “facilitate transparency between the review team and device manufacturers.”
Read the full article here.
More articles on supply chain:
Trump threatens to hike tariffs on China if deal not reached
10 hospitals seeking supply chain talent
FDA still allowing devicemakers to shield medical device safety flaws from the public
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.
