21 CFR § 809.20 In Vitro Diagnostic Products for Human Use

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

Current through Sep 8, 2026 · Read all of Part 809

(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]

← § 809.11 Exceptions or alternatives to labeling requirements for in vitro diagnostic products for human use held by the Strategic National Stockpile.§ 809.30 Restrictions on the sale, distribution and use of analyte specific reagents. →