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89 FR (09/30/2024) » 2024-22332. Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment; Guidance for Industry and Food and Drug Administration Staff; Availability
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