§ 493.15 Laboratories performing waived tests.

(a) Requirement. Tests for certificate of waiver must meet the descriptive criteria specified in paragraph (b) of this section.

(b) Criteria. Test systems are simple laboratory examinations and procedures which—

(1) Are cleared by FDA for home use;

(2) Employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or

(3) Pose no reasonable risk of harm to the patient if the test is performed incorrectly.