CFR section
21 CFR 821.25(a): 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(a) |
|---|---|
| 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) | (a) A manufacturer of a tracked device shall adopt a method of tracking for each such type of device that it distributes that enables a manufacturer to provide FDA with the following information in writing for each tracked device distributed: (1) Except as required by order under section 518(e) of the act, within 3 working days of a request from FDA, prior to the distribution of a tracked device to a patient, the name, address, and telephone number of the distributor, multiple distributor, or… |
At a glance
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- 1–9 Warning letters citing this section
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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.