2024-21575. Chemical Analysis for Biocompatibility Assessment of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability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 Device Exemption	0910-0332
812	Investigational Device Exemption	0910-0078
860, subpart D	De Novo classification process	0910-0844
“Requests for Feedback on Medical Device Submissions: The Q-Submission Program and Meetings with Food and Drug Administration Staff”	Q-Submissions and Early Payor Feedback Request Programs for Medical Devices	0910-0756