---
kind: "section"
citation: "21 C.F.R. § 809.20"
title: "21"
number: "809.20"
heading: "General requirements for manufacturers and producers of in vitro diagnostic products."
url: "https://uscodex.org/cfr/21/809.20"
---

# §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](/cfr/21/part820.md) of this chapter and, if applicable, with [§ 610.44](/cfr/21/610.44.md) of this chapter.

## Notes

### Amendments

[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]

### Authority

Authority: 21 U.S.C. 321(h)(1), 331, 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 371, 372, 374, 381, and 42 U.S.C. 262.

### Amendments

[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]