1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter H - MEDICAL DEVICES
  5. Part 830 - UNIQUE DEVICE IDENTIFICATION
  6. Subpart D - FDA as an Issuing Agency
  7. 21 CFR § 830.210
21 CFR § 830.210
Eligibility for use of FDA as an issuing agency
June 25, 2020
CFR

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.

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§ 830.200 When FDA will act as an issuing agency

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