CFR section
21 CFR 830.320(a): Submission of unique device identification information
PART 830-UNIQUE DEVICE IDENTIFICATION · Subpart E-Global Unique Device Identification Database
Key facts
| Citation | 21 CFR 830.320(a) |
|---|---|
| Section | Submission of unique device identification information |
| Part | PART 830-UNIQUE DEVICE IDENTIFICATION |
| Subpart | Subpart E-Global Unique Device Identification Database |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices |
| Regulation text (excerpt) | (a) Designation of contact for device identification. Each labeler must designate an individual to serve as the point of contact with FDA on matters relating to the identification of medical devices marketed by the labeler. The contact for device information is responsible for ensuring FDA is provided with all information required by this part. The contact for device information may authorize an issuing agency or any other person to provide information to FDA on behalf of the labeler. |
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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.