FDA provides new draft guidance on premarket submissions for device software functions

Nov. 8, 2021

The following quote is attributed to 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 healthcare, 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.

We’re publishing a draft guidance that describes the information that the FDA considers important during its evaluation of the safety and effectiveness for device software with one or more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 We anticipate this draft guidance, which fulfills FDA’s commitment in MDUFA IV, will provide clarity, simplicity and harmonization with current best practices and recognized voluntary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

We look forward to receiving comments on this draft guidance and to providing final guidance to stakeholders as part of our efforts to promote innovation of safe and effective devices for the benefit of public health.”

FDA press release