§892.1. Scope. — Inbound Citations

21 C.F.R. § 892.1

Statutory Authority

Cited by 2 regulations in release Current.

21 C.F.R. § 892.1180(b)

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(b) Class II (special controls). The special control for this device is FDA's “Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Bone Sonometers.” See § 892.1(e) for the availability of this guidance document.
21 C.F.R. § 892.1715(b)

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(b) Class II (special controls). The special control for the device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Full-Field Digital Mammography System.” See § 892.1(e) for the availability of this guidance document.