21 CFR § 1.1410 General Enforcement Regulations

§ 1.1410 When will FDA consider whether to waive a requirement of this subpart?

Current through Sep 8, 2026 · Read all of Part 1

FDA will consider whether to waive a requirement of this subpart on our own initiative or in response to the following:

(a) A written request for a waiver for an individual entity; or

(b) A citizen petition requesting a waiver for a type of entity submitted under § 10.30 of this chapter by any person subject to the requirements of this subpart.

← § 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?§ 1.1415 How may I request a waiver for an individual entity? →