§884.6150. Assisted reproduction micromanipulators and microinjectors.
21 C.F.R. § 884.6150
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.
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.
Notes, amendments, and revision history
Amendments
[45 FR 12684, Feb. 26, 1980, as amended at 84 FR 71816, Dec. 30, 2019]
Source
Source: 63 FR 48436, Sept. 10, 1998, unless otherwise noted.
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l , 371.
Source
Source: 45 FR 12684, Feb. 26, 1980, unless otherwise noted.
Amendments
[45 FR 12684, Feb. 26, 1980, as amended at 84 FR 71816, Dec. 30, 2019]