MobiHealth News September 15, 2023
The FDA clarifies its interpretation of “more effective,” and indicates it will consider improved accessibility of a device during the Breakthrough designation process.
On Thursday, the FDA Center for Devices and Radiological Health released updated final guidance for its Breakthrough Devices Program, aimed at verifying medical devices on the market are safe and effective, and improve healthcare inequities.
The final guidance defines the FDA’s interpretation of “more effective” as encompassing all the information about the device, including the risks and benefits of using the device compared to the standard of care, as well as its potential to make a clinically meaningful impact.
It also explains that the program may be available for certain nonaddictive medical products to treat...
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