CFR section
21 CFR 1003.21(a): Notification by the manufacturer to affected persons
PART 1003-NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY · Subpart C-Notification
Key facts
| Citation | 21 CFR 1003.21(a) |
|---|---|
| Section | Notification by the manufacturer to affected persons |
| Part | PART 1003-NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY |
| Subpart | Subpart C-Notification |
| Subchapter | 21 CFR J Radiological |
| Product types cited | Devices |
| Regulation text (excerpt) | (a) The notification to the persons specified in § 1003.10(b) shall be in writing and, in addition to other relevant information which the Secretary may require, shall include: (1) The information prescribed by § 1003.20 (a), (d), and instructions with respect to the use of the product pending the correction of the defect; (2) A clear evaluation in nontechnical terms of the hazards reasonably related to any defect or failure to comply; and (3) The following statement: The manufacturer will… |
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.