Subjgrp 94. Waivers

• § 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 - When will FDA consider whether to waive a requirement of this subpart?
• § 1.1415 - How may I request a waiver for an individual entity?
• § 1.1420 - What process applies to a request for a waiver for an individual entity?
• § 1.1425 - What must be included in a petition requesting a waiver for a type of entity?
• § 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 - What process applies to a petition requesting a waiver for a type of entity?
• § 1.1440 - What process will FDA follow when waiving a requirement of this subpart on our own initiative?
• § 1.1445 - Under what circumstances may FDA modify or revoke a waiver?
• § 1.1450 - What procedures apply if FDA tentatively determines that a waiver should be modified or revoked?