Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions; Guidance for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance entitled "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions." This guidance demonstrates FDA's commitment to developing innovative approaches to the regulation of artificial intelligence (AI)-enabled devices. More specifically, this guidance provides recommendations on the information to include in a Predetermined Change Control Plan (PCCP) in a marketing submission for a device that includes one or more AI-enabled device software functions (AI-DSFs). This guidance recommends that a PCCP describe the planned AI-DSF modifications, the associated methodology to develop, validate, and implement those modifications, and an assessment of the impact of those modifications. FDA reviews the PCCP as part of a marketing submission for a device to ensure the continued safety and effectiveness of the device without necessitating additional marketing submissions for implementing each modification described in the PCCP.

Abstract as published in the Federal Register.

The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.