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

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§ 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]

Title 21 published on 10-May-2017 03:43

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 809 after this date.

  • 2016-06-15; vol. 81 # 115 - Wednesday, June 15, 2016
    1. 81 FR 38911 - Use of Symbols in Labeling
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective September 13, 2016.
      21 CFR Parts 660, 801, and 809