2024-22332. Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment; Guidance for Industry and Food and Drug Administration Staff; Availability  

  • 21 CFR Part or FDA Form Topic OMB Control No.
    1002, 1005, 1010, 1020, 1030, 1040, and 1050; form FDA 2579 and form FDA 2877 Reporting and Recordkeeping for Electronic Products—General Requirements 0910-0025
    800, 801, and 809 Labeling 0910-0485
    812 Investigational Device Exemption 0910-0078
    “Allegations of Regulatory Misconduct” form Voluntary Allegations of Regulatory Misconduct 0910-0769

Document Information

Published:
09/30/2024
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice of availability.
Document Number:
2024-22332
Dates:
The announcement of the guidance is published in the Federal Register on September 30, 2024.
Pages:
79624-79626 (3 pages)
Docket Numbers:
Docket No. FDA-2018-D-4115
PDF File:
2024-22332.pdf