§807.81. When a premarket notification submission is required. — Inbound Citations

21 C.F.R. § 807.81

Statutory Authority

Cited by 2 regulations in release Current.

21 C.F.R. § 801.128(e)(1)

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(1) The Center Director may determine that the submission and grant of a written request under this section satisfies the provisions relating to premarket notification submissions under § 807.81(a)(3) of this chapter.
21 C.F.R. § 809.11(e)(1)

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(1) The Center Director may determine that the submission and grant of a written request under this section satisfies the provisions relating to premarket notification submissions under § 807.81(a)(3) of this chapter.