2024-15337. Dental Composite Resin Devices and Dental Curing Lights-Premarket Notification (510(k)) Submissions Guidances; Draft Guidances for Industry and Food and Drug Administration Staff; Availability  

  • 21 CFR part or guidance Topic OMB control No.
    807, subpart E Premarket notification 0910-0120
    812 Investigational Device Exemption 0910-0078
    “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
    50, 56 Protection of Human Subjects and Institutional Review Boards 0910-0130

Document Information

Published:
07/12/2024
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice of availability.
Document Number:
2024-15337
Dates:
Submit either electronic or written comments on the draft guidance by September 10, 2024 to ensure that the Agency considers your comment on the draft guidance before it begins work on the final version of the guidance.
Pages:
57155-57157 (3 pages)
Docket Numbers:
Docket Nos. FDA-2024-D-2511 and FDA-2024-D-2512
PDF File:
2024-15337.pdf