CFR section
21 CFR 1002.20(a): Reporting of accidental radiation occurrences
PART 1002-RECORDS AND REPORTS · Subpart C-Manufacturers' Reports on Accidental Radiation Occurrences
Key facts
| Citation | 21 CFR 1002.20(a) |
|---|---|
| Section | Reporting of accidental radiation occurrences |
| Part | PART 1002-RECORDS AND REPORTS |
| Subpart | Subpart C-Manufacturers' Reports on Accidental Radiation Occurrences |
| Subchapter | 21 CFR J Radiological |
| Product types cited | Devices |
| Regulation text (excerpt) | (a) Manufacturers of electronic products shall, where reasonable grounds for suspecting that such an incident has occurred, report to the Director, Center for Devices and Radiological Health, all accidental radiation occurrences reported to or otherwise known to the manufacturer and arising from the manufacturing, testing, or use of any product introduced or intended to be introduced into commerce by such manufacturer. Reasonable grounds include, but are not necessarily limited to, professional… |
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Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.