2024-27661. Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices; Guidance for Industry and Food and Drug Administration Staff; Availability

21 CFR Part; Guidance; or FDA Form	Topic	OMB control No.
814, subparts A through E	Premarket approval	0910-0231
814, subpart H	Humanitarian Use Devices; Humanitarian Device Exemption	0910-0332
“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
807, subparts A through D	Electronic Submission of Medical Device Registration and Listing	0910-0625