CFR section
21 CFR 821.20(a): Devices subject to tracking
PART 821-MEDICAL DEVICE TRACKING REQUIREMENTS · Subpart B-Tracking Requirements
Key facts
| Citation | 21 CFR 821.20(a) |
|---|---|
| Section | Devices subject to tracking |
| 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 any class II or class III device that fits within one of the three criteria within § 821.1(a) must track that device in accordance with this part, if FDA issues a tracking order to that manufacturer. |
At a glance
- 1–9 Inspections citing this section
- None 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.