CFR section
21 CFR 821.25(c)(1): Device tracking system and content requirements: manufacturer requirements
PART 821-MEDICAL DEVICE TRACKING REQUIREMENTS · Subpart B-Tracking Requirements
Key facts
| Citation | 21 CFR 821.25(c)(1) |
|---|---|
| Section | Device tracking system and content requirements: manufacturer requirements |
| Part | PART 821-MEDICAL DEVICE TRACKING REQUIREMENTS |
| Subpart | Subpart B-Tracking Requirements |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices |
| Regulation text (excerpt) | (1) Data collection and recording procedures, which shall include a procedure for recording when data which is required under this part is missing and could not be collected and the reason why such required data is missing and could not be collected; |
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About CFR sections cited by the FDA
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.