2024-28361. 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

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
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
800, 801, 809, and 830	Medical Device Labeling Regulations; Unique Device Identification	0910-0485
820	Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation	0910-0073
822	Postmarket Surveillance of Medical Devices	0910-0449
50, 56	Protection of Human Subjects and Institutional Review Boards	0910-0130
58	Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies	0910-0119