AdvaMed says FDA proposal for new medical device program unclear

The FDA is trying to create a new program to allow patients faster access to lifesaving medical devices, but the Advanced Medical Technology Association, a lobbying group that represents 97 percent of the country's medical devicemakers, said the agency needs to refine the program's requirements, according to MedTech Dive

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AdvaMed said that while it supports the FDA's efforts to speed up access to medical devices, the draft guidance for the program it released Sept. 19 isn't clear on what kind of devices would be eligible.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."

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