§888.4800. Template for clinical use.
21 C.F.R. § 888.4800
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.
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.
Notes, amendments, and revision history
Amendments
[52 FR 33702, Sept. 4, 1987, as amended at 66 FR 38815, July 25, 2001]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l , 371.
Source
Source: 52 FR 33702, Sept. 4, 1987, unless otherwise noted.
Amendments
[52 FR 33702, Sept. 4, 1987, as amended at 66 FR 38815, July 25, 2001]