21 CFR 809.20 - General requirements for manufacturers and producers of in vitro diagnostic products.

U.S. Code of Federal Regulations

Regulations most recently checked for updates: Aug 28, 2025

View all text of Subpart C [§ 809.20 - § 809.40]

§ 809.20 - General requirements for manufacturers and producers of in vitro diagnostic products.

(a) [Reserved]

(b) Compliance with good manufacturing practices. In vitro diagnostic products shall be manufactured in accordance with the good manufacturing practices requirements found in part 820 of this chapter and, if applicable, with § 610.44 of this chapter.

[41 FR 6903, Feb. 13, 1976, as amended at 42 FR 42530, Aug. 23, 1977; 43 FR 31527, July 21, 1978; 66 FR 31165, June 11, 2001]