CFR section
21 CFR 830.310(b): Information required for unique device identification
PART 830-UNIQUE DEVICE IDENTIFICATION · Subpart E-Global Unique Device Identification Database
Key facts
| Citation | 21 CFR 830.310(b) |
|---|---|
| Section | Information required for unique device identification |
| 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) | (b) Concerning each version or model of a device with a UDI on its label: (1) The device identifier portion of the UDI assigned to the version or model; (2) When reporting a substitution of a new device identifier that will be used in lieu of a previously reported identifier, the device identifier that was previously assigned to the version or model; (3) If § 801.45 of this chapter requires the device to bear a UDI as a permanent marking on the device itself, either: (i) A statement that the… |
At a glance
- 10–99 Inspections citing this section
- 1–9 Warning letters citing this section
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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.