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FDA In Brief: FDA Provides New Draft Guidance on Premarket Submissions for Device Software Functions

For Immediate Release:

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Today, we’re publishing a draft guidance that describes the information that the FDA considers important during its evaluation of the safety and effectiveness for device software with one or more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 We anticipate this draft guidance, which fulfills FDA’s commitment in MDUFA IV, will provide clarity, simplicity and harmonization with current best practices and recognized voluntary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


We look forward to receiving comments on this draft guidance and to providing final guidance to stakeholders as part of our efforts to promote innovation of safe and effective devices for the benefit of public health.”

Additional Information

  • Today, the FDA is making available the draft guidance Content of Premarket Submissions for Device Software Functions intended to provide information regarding the recommended documentation to include in premarket submissions for the FDA to evaluate the safety and effectiveness of device software functions.
  • The proposed recommendations in this draft guidance document pertain to device software functions, including both software in a medical device (SiMD) and software as a medical device (SaMD), and describe a subset of information that would be typically 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 MDUFA IV Digital Health commitments.

Related Information

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


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