---
kind: "section"
citation: "42 C.F.R. § 493.25"
title: "42"
number: "493.25"
heading: "Laboratories performing tests of high complexity."
url: "https://uscodex.org/cfr/42/493.25"
---

# §493.25. Laboratories performing tests of high complexity.

- (a) A laboratory must obtain a certificate for tests of high complexity if it performs one or more tests that meet the criteria for tests of high complexity as specified in [§ 493.17(a)](/cfr/42/493.17.md?p=a).
- (b) A laboratory performing one or more tests of high complexity must meet the applicable requirements of subpart C or subpart D, and subparts F, H, J, K, M, and Q of this part.
- (c) If the laboratory also performs tests of moderate complexity, the applicable requirements of subparts [H](/cfr/42/subpartH.md), [J](/cfr/42/subpartJ.md), K, M, and Q of this part must be met. Under a registration certificate or certificate of compliance, PPM procedures must meet the inspection requirements at §§ [493.1773](/cfr/42/493.1773.md) and [493.1777](/cfr/42/493.1777.md).
- (d) If the laboratory also performs waived tests, compliance with §§ [493.801(a)](/cfr/42/493.801.md?p=a) and [493.801(b)(7)](/cfr/42/493.801.md?p=b-7) and subparts [J](/cfr/42/subpartJ.md), [K](/cfr/42/subpartK.md), and M of this part are not applicable to the waived tests. However, the laboratory must comply with the requirements in §§ [493.15(e)](/cfr/42/493.15.md?p=e), [493.801(b)(1) through (6)](/cfr/42/493.801.md?p=b-1..b-6), [493.1771](/cfr/42/493.1771.md), [493.1773](/cfr/42/493.1773.md), and [493.1775](/cfr/42/493.1775.md).

## Notes

### Amendments

[57 FR 7139, Feb. 28, 1992, as amended at 60 FR 20044, Apr. 24, 1995; 68 FR 3702, Jan. 24, 2003; 68 FR 50723, Aug. 22, 2003; 87 FR 41232, July 11, 2022]

### Source

Source: 57 FR 7139, Feb. 28, 1992, unless otherwise noted.

### Authority

Authority: 42 U.S.C. 263a, 1302, 1395x(e), 1395x(s)(3) and (s)(17).

### Source

Source: 55 FR 9576, Mar. 14, 1990, unless otherwise noted.

### Amendments

[57 FR 7139, Feb. 28, 1992, as amended at 60 FR 20044, Apr. 24, 1995; 68 FR 3702, Jan. 24, 2003; 68 FR 50723, Aug. 22, 2003; 87 FR 41232, July 11, 2022]