Two primary areas of U.S. regulation of the performance of genetic testing by clinical laboratories are described: regulation of genetic tests and regulation of laboratories. Pursuant to its authority under the Federal Food, Drug, and Cosmetic Act, the U.S. Food and Drug Administration (FDA) regulates laboratory tests that are sold as kits as diagnostic medical devices. Historically, the FDA has asserted regulatory authority only as regards the active ingredients used in such tests, which are known as analyte-specific reagents (ASRs). However, the FDA could be more carefully evaluating whether the less rigid rules applied to home-brew tests and ASRs permit certain genetic tests or components to be marketed without suitable safeguards. There is no federal regulation of genetic tests as such and no federal regulation of test kits reagents, or support tools used by laboratories outside the U.S. However, New York State has taken the position that it is authorized to review and approve genetic tests that are done on blood or other tissue samples that originate in New York, even if tests are developed, manufactured, purchased, and conducted outside the U.S. The Clinical Laboratory Improvement Act of 1988 and implementing regulations (CLIA) determines the federal laboratory regulatory regime. States can regulate laboratories under three categories: states that regulate genetic tests and the labs that conduct tests with respect to specimens originating within their boundaries; states that regulate laboratories conducting tests with respect to specimens originating within their boundaries, but that do not regulate genetic tests themselves; and states that do not set laboratory licensing or regulatory requirements on foreign laboratories conducting genetic tests on specimens originating within their boundaries.