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The FDA Issues Draft Guidance on the Content of Premarket Submissions for Device Software Functions Today, the U.S. Food and Drug Administration (FDA) issued the draft guidance: Content of Premarket Submissions for Device Software Functions. The draft guidance is intended to reflect FDA's most current thinking on the recommended documentation sponsors should include in premarket submissions for FDA's evaluation of the safety and effectiveness of device software functions, including both software in a medical device (SiMD) and software as a medical device (SaMD). The proposed recommendations are intended to streamline the organization and content of the software documentation and provide helpful prompts and tips to identify the minimum amount of information that, based on FDA's experience, would generally be needed to support a premarket submission for a device that uses software. The draft guidance proposes recommendations that apply to all types of premarket submissions that include device software functions. When final, it will replace the FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued on May 11, 2005. Submit Comments on the Draft Guidance This draft guidance will be open for public comments for 90 days at https://www.regulations.gov under Docket Number FDA-2021-D-0775. Upcoming webinar on this guidance On December 16, 2021, the FDA will host a webinar for medical device manufacturers and others interested in learning more about the draft guidance. Questions? If you have questions about this draft guidance, contact the Division of Industry and Consumer Education. | 
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