CFR section
21 CFR 821.25(c)(3): 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)(3) |
|---|---|
| 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) | (3) A quality assurance program that includes an audit procedure to be run for each device product subject to tracking, at not less than 6-month intervals for the first 3 years of distribution and at least once a year thereafter. This audit procedure shall provide for statistically relevant sampling of the data collected to ensure the accuracy of data and performance testing of the functioning of the tracking system. |
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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.