The FDA has issued a draft guidance for the Digital Health and the 21st Century Cures Act, an attempt to clarify its policy for devices with more than one function.
Manufacturers can now submit comments to the docket until June 26, according to a press release from the administration.
The draft guidance is entitled, “Multiple function device products: Policy and considerations; draft guidance for industry and food and drug administration staff,” and states that, when assessing a multiple-function device product, manufacturers and the FDA should determine whether any other function may impact the safety or effectiveness of the device function under the FDA’s premarket review, according to the release.
This draft guidance is part of the FDA’s long-term Digital Health Innovation Action Plan and seeks to provide clarity for manufacturers, FDA staff and other stakeholders on the medical software provisions of the 21st Century Cures Act, according to the release.
The FDA will host an interactive session to discuss the progress the agency has made on the Software Precertification Pilot program on May 10.