Waivers

1. CFR
2. ›
3. Title 21
4. ›
5. Chapter I
6. ›
7. Part 1
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9. Subpart S
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11. Subject Group Waivers

Sections

Section numbering in the official eCFR can be non-consecutive. Omitted section numbers are not treated here as reserved unless the source explicitly labels them that way.

• 1.1405
  § 1.1405 Under what circumstances will FDA waive one or more of the requirements of this subpart for an individual entity or a type of entity?
• 1.1410
  § 1.1410 When will FDA consider whether to waive a requirement of this subpart?
• 1.1415
  § 1.1415 How may I request a waiver for an individual entity?
• 1.1420
  § 1.1420 What process applies to a request for a waiver for an individual entity?
• 1.1425
  § 1.1425 What must be included in a petition requesting a waiver for a type of entity?
• 1.1430
  § 1.1430 What information submitted in a petition requesting a waiver for a type of entity, or information in comments on such a petition, is publicly available?
• 1.1435
  § 1.1435 What process applies to a petition requesting a waiver for a type of entity?
• 1.1440
  § 1.1440 What process will FDA follow when waiving a requirement of this subpart on our own initiative?
• 1.1445
  § 1.1445 Under what circumstances may FDA modify or revoke a waiver?
• 1.1450
  § 1.1450 What procedures apply if FDA tentatively determines that a waiver should be modified or revoked?