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89 FR (07/12/2024) » 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
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- Submit either electronic or written comments on the draft guidance by September 10, 2024 to ensure that the Agency considers your comment on the draft guidance before it begins work on the final version of the guidance.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