FDA does not regulate clinical labo

FDA does not regulate clinical laboratories; the Centers for Medicare and Medicaid (CMS) are responsible for compliance with CLIA. For drug studies, clinical laboratories are listed on the FDA Form 1572 so the study sponsor is knowledgeable of the laboratories used should there be concerns, e.g., if a particular study site has laboratory results disparate from the other sites in the study. FDA investigators do not usually question the qualifications of a clinical laboratory when conducting a bioresearch monitoring (BIMO) inspection of a clinical study site. (See the Compliance ProgramGuidance Manual (CPGM) for the inspection of clinical investigators for what is ordinarily inspected -