GroundRules
21 CFR 830.210: Eligibility for use of FDA as an issuing agency.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 830—UNIQUE DEVICE IDENTIFICATION
- Subpart D—FDA as an Issuing Agency
When FDA acts as an issuing agency, any labeler will be permitted to use FDA's unique device identification system, regardless of whether the labeler is considered a small business.
Collected 2026-08-27T02:24:47Z. Source file · JSON