The U.S. FDA has published draft guidance focusing on the recommended documentation to include in premarket submissions for the agency to evaluate the safety and effectiveness of device software functions. The draft guidance document is titled “Content of Premarket Submissions for Device Software Functions.”
“As technology continues to advance all facets of health care, software has become an important part of many products and is integrated widely into medical devices,” says Bakul Patel, MSEE, MBA, director of FDA’s Digital Health Center of Excellence in the Center for Devices and Radiological Health. “The FDA recognizes this evolving landscape and seeks to provide our latest thinking on regulatory considerations for device software functions that is aligned with current standards and best practices.”
The proposed recommendations in this document pertain to device software functions, including both software in a medical device and software as a medical device, and describe a subset of information that typically would be generated and documented during software design, development, verification, and validation.
When final, this guidance will replace the FDA’s “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” issued on May 11, 2005, and will update the FDA’s recommendations on the appropriate documentation for the review of device software functions in premarket submissions.
The FDA committed to publish this draft revised version of the “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” (issued in 2005) as part of the Medical Device User Fee Amendments (MDUFA) IV Digital Health commitments.
“We anticipate this draft guidance, which fulfills FDA’s commitment in MDUFA IV, will provide clarity, simplicity, and harmonization with current best practices and recognized voluntary consensus standards, once finalized,” Patel says. “We look forward to receiving comments on this draft guidance and to providing final guidance to stakeholders as part of our efforts to promote innovation of safe and effective devices for the benefit of public health.”
- Content of Premarket Submissions for Device Software Functions. U.S. Food and Drug Administration. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-premarket-submissions-device-software-functions. Published November 2021. Accessed Nov. 4, 2021.
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. U.S. Food and Drug Administration. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-content-premarket-submissions-software-contained-medical-devices. Published May 2021. Accessed Nov. 4, 2021.