21 C.F.R. § 890.5700

Current through October 31, 2024
Section 890.5700 - Cold pack
(a)Identification. A cold pack is a device intended for medical purposes that consists of a compact fabric envelope containing a specially hydrated pliable silicate gel capable of forming to the contour of the body and that provides cold therapy for body surfaces.
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807. The device also is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820, with the exception of § 820.180 , with respect to general requirements concerning records, and § 820.198 , with respect to complaint files.

21 C.F.R. §890.5700