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Code of Federal Regulations (Last Updated: July 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter J - Radiological Health |
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Part 1003 - Notification of Defects or Failure to Comply |
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Subpart D - Exemptions From Notification Requirements |
§ 1003.30 - Application for exemption from notification requirements.
Latest version.
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§ 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.