When, however, this document reiterates a requirement imposed by law or regulation, the requirement is law, and its force and effect are not changed in any way by virtue of its inclusion in this guidance. CLIA expands regulation of laboratory testing and imposes minimum requirements to ensure the accuracy of tests, assays, or examinations of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or the impairment of, or assessment of the health of human beings. This guidance document represents the Agency's current thinking on the interpretation of section 216 of the Food and Drug Administration Modernization Act of 1997. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.
Laboratories performing only waived tests are subject to minimal regulation.
Laboratories performing moderate or high complexity tests are subject to specific laboratory standards governing certification, personnel, proficiency testing, patient test management, quality assurance, quality control, and inspections. These instructions are summarized in the following table.