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Federal regulations · Through 2026-08-25 · Newer source version available

21 CFR 1003.30: Application for exemption from notification requirements.

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Where this section sits in the code
  1. Title 21—Food and Drugs
  2. CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  3. SUBCHAPTER J—RADIOLOGICAL HEALTH
  4. PART 1003—NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY
  5. Subpart D—Exemptions From Notification Requirements

(a) A manufacturer may at the time of giving the written confirmation required by § 1003.20 or within 15 days of the receipt of any notice from the Secretary pursuant to § 1003.11(a), apply for an exemption from the requirement of notice to the persons specified in § 1003.10(b).

(b) The application for exemption shall contain the information required by § 1003.20 and in addition shall set forth in detail the grounds upon which the exemption is sought.

Collected 2026-08-27T02:24:47Z. Source file · JSON

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