21 CFR § 1003.30 - Application for exemption from notification requirements.

---
identifier: "/us/cfr/t21/s1003.30"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 1003.30 - Application for exemption from notification requirements."
title_number: 21
title_name: "Food and Drugs"
section_number: "1003.30"
section_name: "Application for exemption from notification requirements."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "J"
subchapter_name: "RADIOLOGICAL HEALTH"
part_number: "1003"
part_name: "NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360hh-360ss."
regulatory_source: "38 FR 28628, Oct. 15, 1973, unless otherwise noted."
cfr_part: "1003"
---


# 1003.30 Application for exemption 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.