Summary:

On December 16, 2021, the U.S. Food and Drug Administration (FDA) hosted a webinar for medical device manufacturers and other interested stakeholders to discuss the draft guidance: Content of Premarket Submissions for Device Software Functions. The draft guidance is intended to reflect FDA's most current thinking on the recommended documentation sponsors should include in premarket submissions for FDA's evaluation of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The FDA provided an overview of the draft guidance and responded to questions.

Background:

This draft guidance, Content of Premarket Submissions for Device Software Functions, was issued on November 4, 2021. It proposes recommendations that apply to all types of premarket submissions that include one or more 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.

Meeting Materials:

Presentation, printable slides, and transcript are available at CDRH Learn – Specialty Technical Topics, sub-section “Digital Health”