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Submit either electronic or written comments on the draft guidance by December 5, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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