21 CFR 888.4800
§ 888.4800 Template for clinical use.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 888.4800, § 888.4800 Template for clinical use, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91147
- Permanent ID
ys:prov:91147@1- SHA-256
19e25a7502a7108d8b6bd4931428627a69d8aed65225d469bf5814a04fac6aea
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.