Regulatory Developments in Genetic Testing in the United States

 I found information that summarizes the various US regulatory bodies involvement in Genetic Testing at the OECD site (https://www.oecd.org/health/emerging-tech/regulatorydevelopmentsingenetictestingintheunitedstates.htm).  Based on the content, either a US representative to the OECD supplied the content or someone very familiar with the interconnected Agencies and committees provided the details. 

The introduction provides the framework that is then delved into with greater detail in subsequent paragraphs:

Currently in the United States, genetic and non-genetic tests receive the same level of oversight from governmental agencies. Genetic tests are regulated at the federal level through three mechanisms:

1) the Clinical Laboratory Improvement Amendments (CLIA); 2) the Federal Food, Drug, and Cosmetic Act; and 3) during investigational phases, regulations for the Protection of Human Subjects (45 CFR 46, 21 CFR 50, and 21 CFR 56). In addition to the Federal role, oversight of genetic tests is provided by states and private sector organisations. A summary is provided below of the roles of five organisations of the Department of Health and Human Services (DHHS) in oversight of genetic tests: the Centres for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), Health Care Financing Administration (HCFA), Office for Protection from Research Risks (OPRR), and National Institutes of Health (NIH). Although it does not have a regulatory function, the NIH supports research activities that generate knowledge about genetics and genetic testing. The roles of the states and the private sector in oversight also are described.

The general framework discussed here (i.e. multiple Agency and Committee involvement) is representative of all US patient testing where the medical results are used in assessing patient health and administering appropriate care.