2024-31543. Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

21 CFR part; guidance; or FDA form	Topic	OMB control No.
807, subpart E	Premarket notification	0910-0120
814, subparts A through E	Premarket approval	0910-0231
814, subpart H	Humanitarian Use Devices; Humanitarian Device Exemption	0910-0332
812	Investigational Device Exemption	0910-0078
860, subpart D	De Novo classification process	0910-0844
“Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program”	Q-submissions and Early Payor Feedback Request Programs for Medical Devices	0910-0756
820	Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation	0910-0073
800, 801, 809, and 830	Medical Device Labeling Regulations; Unique Device Identification	0910-0485