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