 
Today, the U.S. Food and Drug Administration (FDA) issued the draft guidance: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions. The draft guidance proposes recommendations on information to include in a Predetermined Change Control Plan in a marketing submission for a machine learning-enabled device software function.
This draft guidance incorporates comments and feedback from the April 2019 Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) discussion paper. The development and release of this draft guidance represents the next step in the FDA’s work to develop a regulatory framework for AI/ML-based software as described in the January 2021 FDA’s Artificial Intelligence/Machine Learning (AI/ML) Software as a Medical Device Action Plan. The issuance of this draft guidance demonstrates the FDA’s broader commitment to developing innovative approaches to the regulation of device software functions. This draft guidance proposes a least burdensome approach to support iterative improvement through modifications to an AI/ML-enabled device, while continuing to provide a reasonable assurance of device safety and effectiveness.
CDRH is committed to advancing health equity as an important focus of our Strategic Priorities (for example, with respect to race, ethnicity, disease severity, gender, age, etc.), which affirms that digital health technologies should be designed and targeted to meet the needs of diverse groups of patients. For more information about this draft guidance and our commitment to health equity, read this CDRH Statement.
Note: This draft guidance is not for implementation at this time.
Submit comments on this draft guidance
The FDA is requesting your comments and suggestions for this draft guidance. This draft guidance will be open for public comments for 90 days at www.Regulations.gov under docket number FDA-2022-D-2628. Submit comments by July 3, 2023, to ensure the FDA considers comments on this draft guidance before it begins work on the final version.
Upcoming webinar on this guidance
On April 13, 2023, the FDA will host a webinar for industry, healthcare providers, and others interested in learning more about the draft guidance.
Questions?
If you have questions about the draft guidance, contact digitalhealth@fda.hhs.gov. If you have questions about the webinar, contact the Division of Industry and Consumer Education.
|
