21 C.F.R. § 1.1410

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

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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.