Table 1 Definitions and relationships between bodies who regulate human genomic medicine research in the United States.
From: FDA oversight of NSIGHT genomic research: the need for an integrated systems approach to regulation
Department of Health and Human Services (DHHS) houses 11 operating divisions, including the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS): ↓ FDA ensures that food is safe; human and animal drugs, biologics, and medical devices are safe and effective. ↓ Within FDA, the Center for Devices and Radiological Health (CDRH) regulates in vitro diagnostic medical devices and issues Investigational Device Exemptions (IDE). | |
Investigational Device Exemption (IDE) | An IDE permits the use of an investigational medical device in a clinical study in order to collect safety and effectiveness data. |
An appropriately constituted group that has been formally designated by its local institution and empowered by the FDA to review and monitor biomedical research involving human subjects. | |
In addition to providing oversight of the Medicare program and the federal portion of other programs, CMS oversees certain quality assurance activities: ↓ The Clinical Laboratory Improvement Amendments (CLIA) program is tasked with regulating laboratories that perform testing on patient specimens to ensure the accuracy and reliability of test results. ↓ A Laboratory Developed Test (LDT) is an in vitro diagnostic test that is manufactured by and used by a single laboratory. |
