21 C.F.R. § 888.4800

Current through May 31, 2024
Section 888.4800 - Template for clinical use
(a)Identification. A template for clinical use is a device that consists of a pattern or guide intended for medical purposes, such as selecting or positioning orthopedic implants or guiding the marking of tissue before cutting.
(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 .

21 C.F.R. §888.4800

52 FR 33702, Sept. 4, 1987, as amended at 66 FR 38815, July 25, 2001