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89 FR (09/06/2024) » 2024-20069. Incorporating Voluntary Patient Preference Information Over the Total Product Life Cycle; Guidance for Industry, Food and Drug Administration Staff and Other Interested Parties; Availability
2024-20069. Incorporating Voluntary Patient Preference Information Over the Total Product Life Cycle; Guidance for Industry, Food and Drug Administration Staff and Other Interested Parties; 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 Use Devices; Humanitarian Device Exemption |
0910-0332 |
812 |
Investigational Device Exemption |
0910-0078 |
860, subpart D |
De Novo classification process |
0910-0844 |
“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 |
50, 56 |
Protection of Human Subjects and Institutional Review Boards |
0910-0130 |
Document Information
- Published:
- 09/06/2024
- Department:
- Food and Drug Administration
- Entry Type:
- Notice
- Action:
- Notice of availability.
- Document Number:
- 2024-20069
- Dates:
- Submit either electronic or written comments on the draft guidance by December 5, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
- Pages:
- 72856-72858 (3 pages)
- Docket Numbers:
- Docket No. FDA-2015-D-1580
- PDF File:
-
2024-20069.pdf