21CFR890.5730

(a) Identification. A moist heat pack is a device intended for medical purposes that consists of silica gel in a fabric container used to retain an elevated temperature and that provides moist heat 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 of this chapter , subject to the limitations in § 890.9 . The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter , except for requirements concerning records and complaint files under § 820.35 of this chapter .