21 CFR 878.3800
§ 878.3800 External aesthetic restoration prosthesis.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 878.3800, § 878.3800 External aesthetic restoration prosthesis, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90398
- Permanent ID
ys:prov:90398@1- SHA-256
f2d3c15550ea8aad129cff5f39a240d92cb0940bae5adc2088fe49982a5c8855
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
(a) Identification. An external aesthetic restoration prosthesis is a device intended to be used to construct an external artificial body structure, such as an ear, breast, or nose. Usually the device is made of silicone rubber and it may be fastened to the body with an external prosthesis adhesive. The device is not intended to be implanted.
(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 § 878.9. If the device is intended for use without an external prosthesis adhesive to fasten it to the body, the device is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.