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