2024-15130. Clinical Considerations for Studies of Devices Intended To Treat Opioid Use Disorder; 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
“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
860, subpart D	De Novo classification process	0910-0844