21 C.F.R. § 884.6150 Assisted reproduction micromanipulators and microinjectors.
Title 21 - Food and Drugs
(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).
Title 21: Food and Drugs
PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES
Subpart G—Assisted Reproduction Devices
§ 884.6150 Assisted reproduction micromanipulators and microinjectors.
