2024-27085. 510(k) Third Party Review Program and Third Party Emergency Use Authorization Review; Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations; Availability

21 CFR part; guidance; or FDA form	Topic	OMB control No.
“510(k) Third Party Review Program”	510(k) Third Party Review Program	0910-0375
“Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff”	Q-submissions	0910-0756
“Emergency Use Authorization of Medical Products and Related Authorities; Guidance for Industry and Other Stakeholders”	Emergency Use Authorization	0910-0595
“Guidance for Industry and Food and Drug Administration Staff; Center for Devices and Radiological Health Appeals Processes”	CDRH Appeals Processes	0910-0738

Document Information

Published:: 11/21/2024
Department:: Food and Drug Administration
Entry Type:: Notice
Action:: Notice of availability.
Document Number:: 2024-27085
Dates:: The announcement of the guidance is published in the Federal Register on November 21, 2024.
Pages:: 92128-92130 (3 pages)
Docket Numbers:: Docket No. FDA-2016-D-2565
PDF File:: 2024-27085.pdf
Supporting Documents:: » Reference 3 - FDA Draft Guidance entitled Accreditation and Reaccreditation Process for Firms under the Third Party Review Program Part I_ 2013 re 510(k) Third Party Review Program; Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations; Availability; » Reference 2 - International Medical Device Regulators Forum’s Medical Device Single Audit Program documents re 510(k) Third Party Review Program; Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations; Availability; » Reference 1 - List of References for Third Party Review Program Draft Guidance re 510(k) Third Party Review Program; Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations; Availability