42 C.F.R. § 493.25

Current through October 31, 2024
Section 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) .
(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, J, 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 and 493.1777 .
(d) If the laboratory also performs waived tests, compliance with §§ 493.801(a) and 493.801(b)(7) and subparts J, K, and M of this part are not applicable to the waived tests. However, the laboratory must comply with the requirements in §§ 493.15(e) , 493.801(b)(1) through (6) , 493.1771 , 493.1773 , and 493.1775 .

42 C.F.R. §493.25

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
87 FR 41232 , 8/10/2022