Subpart B—Labeling Requirements for Unique Device Identification

1. CFR
2. ›
3. Title 21
4. ›
5. Chapter I
6. ›
7. Part 801
8. ›
9. Subpart B

Sections

Section numbering in the official eCFR can be non-consecutive. Omitted section numbers are not treated here as reserved unless the source explicitly labels them that way.

• 801.20
  § 801.20 Label to bear a unique device identifier.
• 801.30
  § 801.30 General exceptions from the requirement for the label of a device to bear a unique device identifier.
• 801.35
  § 801.35 Voluntary labeling of a device with a unique device identifier.
• 801.40
  § 801.40 Form of a unique device identifier.
• 801.45
  § 801.45 Devices that must be directly marked with a unique device identifier.
• 801.50
  § 801.50 Labeling requirements for stand-alone software.
• 801.55
  § 801.55 Request for an exception from or alternative to a unique device identifier requirement.
• 801.57
  § 801.57 Discontinuation of legacy FDA identification numbers assigned to devices.