- July 20, 2023
- 1:00 PM - 2:00 PM ET
On July 20, 2023, the U.S. Food and Drug Administration (FDA) held a webinar for industry and other interested stakeholders to discuss the final guidance: Content of Premarket Submissions for Device Software Functions.
During this webinar, the FDA:
- Discussed the risk-based approach to determining the recommended documentation level for a premarket submission
- Discussed the recommendations for information to be included in premarket submissions for Basic and Enhanced Documentation Levels.
- Answered questions about the final guidance.
The purpose of this guidance is to describe the FDA's thinking on the recommended documentation sponsors should include in premarket submissions for the FDA's evaluation of the safety and effectiveness of device software functions. This guidance replaces the FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued on May 11, 2005 and describes information that would be typically generated and documented during software development, verification, and validation. This thinking recognizes changes to the FD&C Act made by the 21st Century Cures Act (Cures Act), which amended section 520 of the FD&C Act and excludes certain software functions from the device definition. It also considers the rapidly evolving nature of digital health and recent FDA-recognized consensus standards related to software.
The presentation, printable slides, and transcript are available at CDRH Learn under "Specialty Technical Topics", sub-section "Digital Health."
If you have questions about this guidance document, please contact the CDRH Digital Health Center of Excellence at email@example.com. If you have questions about this webinar, please contact CDRH's Division of Industry and Consumer Education (DICE) at firstname.lastname@example.org, 1-800-638-2041, or 301-796-7100.