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e-CFR data is current as of July 31, 2020

Title 21Chapter ISubchapter HPart 809Subpart C → §809.20


Title 21: Food and Drugs
PART 809—IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE
Subpart C—Requirements for Manufacturers and Producers


§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]

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