Title 21

SECTION 888.4800

888.4800 Template for clinical use.

§ 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.

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