21 C.F.R. § 888.5980 Manual cast application and removal instrument.
Title 21 - Food and Drugs
(a) Identification. A manual cast application and removal instrument is a nonpowered hand-held device intended to be used in applying or removing a cast. This generic type of device includes the cast knife, cast spreader, plaster saw, plaster dispenser, and casting stand. (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 §888.9. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of §820.180, regarding general requirements concerning records, and §820.198, regarding complaint files. [52 FR 33702, Sept. 4, 1987, as amended at 53 FR 52954, Dec. 29, 1988; 66 FR 38816, July 25, 2001]
Title 21: Food and Drugs
PART 888—ORTHOPEDIC DEVICES
Subpart E—Surgical Devices
§ 888.5980 Manual cast application and removal instrument.
