Bakul Patel, director of FDA’s Digital Health Center of Excellence in the Center for Devices and Radiological Health

“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. 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.
Today, we’re publishing a draft guidance that describes the information that the FDA considers important during its evaluation of the safety and effectiveness for device software with one or more device functions, including both software in a medical device and software as a medical device. We anticipate this draft guidance, which fulfills FDA’s commitment in MDUFA IV, will provide clarity, simplicity and harmonization with current best practices and recognized voluntary consensus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."

After many years, FDA published draft guidance for the recommended documentation to include in premarket submissions for the FDA to evaluate the safety and effectiveness of device software functions. 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. In recent years we had a couple projects where guidance document did not match present software technologies, and was quite challenging to prepare the appropriate documentation for the review of device software functions in premarket submissions. We will share our thoughts on the new regulation in a future article. You can download draft version of the new guidance document Content of Premarket Submissions for Device Software Functions using the link enclosed below.
We look forward to the final guidance publication.

Draft guidance

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