CFR section
21 CFR 821.25(c): 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) |
|---|---|
| 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) | (c) A manufacturer of a tracked device shall establish a written standard operating procedure for the collection, maintenance, and auditing of the data specified in paragraphs (a) and (b) of this section. A manufacturer shall make this standard operating procedure available to FDA upon request. A manufacturer shall incorporate the following into the standard operating procedure: (1) Data collection and recording procedures, which shall include a procedure for recording when data which is… |
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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.