CFR section
21 CFR 821.30(a): Tracking obligations of persons other than device manufacturers: distributor requirements
PART 821-MEDICAL DEVICE TRACKING REQUIREMENTS · Subpart C-Additional Requirements and Responsibilities
Key facts
| Citation | 21 CFR 821.30(a) |
|---|---|
| Section | Tracking obligations of persons other than device manufacturers: distributor requirements |
| Part | PART 821-MEDICAL DEVICE TRACKING REQUIREMENTS |
| Subpart | Subpart C-Additional Requirements and Responsibilities |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices |
| Regulation text (excerpt) | (a) A distributor, final distributor, or multiple distributor of any tracked device shall, upon purchasing or otherwise acquiring any interest in such a device, promptly provide the manufacturer tracking the device with the following information: (1) The name and address of the distributor, final distributor or multiple distributor; (2) The unique device identifier (UDI), lot number, batch number, model number, or serial number of the device or other identifier used by the manufacturer to track… |
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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.