The Food and Drug Administration (FDA) regulates "public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices."
The scope of FDA regulations in regard to the clinical laboratory includes:
- Blood and blood products
- Cellular and gene therapy products
- Tissue and tissue products
- Complex technologies (laboratory analyzers)
The FDA must approve new drugs and medical devices before they go to market, including equipment and testing protocols used in the clinical laboratory. The Medical Device Amendments of 1976 apply safeguards to monitor the safety and effectiveness of new devices and to prevent device-related injuries and deaths. The Food and Drug Administration Amendments Act of 2007 (FDAAA) expanded the FDA's legislations even further; it allows the FDA to perform more comprehensive reviews of new drugs and devices, thus ensuring their safety to another degree.
The FDA does not approve companies. However, they have the authority to perform inspections and ensure that good manufacturing practices are being maintained.
The FDA assures quality laboratory testing by:
- Categorizing tests based on complexity
- Reviewing requests for Waiver by Application
- Developing rules and guidance for CLIA complexity categorization