(a) Each laboratory issued a CLIA certificate must meet the requirements in Sec. 493.1773 and the specific requirements for its certificate type, as specified in Sec. Sec. 493.1775 through 493.1780.
(b) All CLIA-exempt laboratories must comply with the inspection requirements in Sec. Sec. 493.1773 and 493.1780, when applicable. [63 FR 26737, May 14, 1998]