---
kind: "section"
citation: "42 C.F.R. § 493.20"
title: "42"
number: "493.20"
heading: "Laboratories performing tests of moderate complexity."
url: "https://uscodex.org/cfr/42/493.20"
---

# §493.20. Laboratories performing tests of moderate complexity.

- (a) A laboratory may qualify for a certificate to perform tests of moderate complexity provided that it restricts its test performance to waived tests or examinations and one or more tests or examinations meeting criteria for tests of moderate complexity including the subcategory of PPM procedures.
- (b) A laboratory that performs tests or examinations of moderate complexity must meet the applicable requirements in [subpart C](/cfr/42/subpartC.md) or [subpart D](/cfr/42/subpartD.md), and subparts [F](/cfr/42/subpartF.md), [H](/cfr/42/subpartH.md), J, K, M, and Q of this part. Under a registration certificate or certificate of compliance, laboratories also performing PPM procedures must meet the inspection requirements at §§ [493.1773](/cfr/42/493.1773.md) and [493.1777](/cfr/42/493.1777.md).
- (c) If the laboratory also performs waived tests, compliance with § [493.801(a)](/cfr/42/493.801.md?p=a) and [(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 is 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

[60 FR 20044, Apr. 24, 1995, as amended at 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

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