21 CFR 884.6150
§ 884.6150 Assisted reproduction micromanipulators and microinjectors.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 884.6150, § 884.6150 Assisted reproduction micromanipulators and microinjectors, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90876
- Permanent ID
ys:prov:90876@1- SHA-256
58637bbd7ff2eb014e0764704c423c05e92efb2477eb414757c72f49e23b2ead
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. Assisted reproduction micromanipulators are devices intended to control the position of an assisted reproduction microtool. Assisted reproduction microinjectors are any device intended to control aspiration or expulsion of the contents of an assisted reproduction microtool.
(b) Classification. Class II (special controls) (design specifications, labeling requirements, and clinical testing). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.