§864.3. Effective dates of requirement for premarket approval. — Inbound Citations

21 C.F.R. § 864.3

Statutory Authority

Cited by 3 regulations in release Current.

21 C.F.R. § 864.1860(c)

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(c) As of May 28, 1976, an approval under section 515 of the Federal Food, Drug, and Cosmetic Act is required for any device described in paragraph (b)(3) of this section before this device may be commercially distributed. See § 864.3.
21 C.F.R. § 864.4020(c)(1)

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(1) Preamendments ASR's; No effective date has been established for the requirement for premarket approval for the device described in paragraph (b)(3) of this section. See § 864.3.
21 C.F.R. § 864.9205(c)

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(c) No effective date has been established of the requirement for premarket approval for the device described in paragraph (b)(1). See § 864.3.