FDA (Food and Drug Administration)
The U.S. Food and Drug Administration (FDA) is a regulatory agency in the US responsible for protecting and promoting public health by ensuring the safety, efficacy, and security of:
- Human and veterinary drugs
- Biological products
- Medical devices
- Food supply
- Cosmetics
- Products that emit radiation
The FDA oversees the approval process for new drugs and medical devices. With that, the FDA sets standards and requirements for product quality, reviews scientific evidence, and provides guidance to industry stakeholders.
FDA´s duties include:
- Regulation of manufacturing
- Regulation of distribution
- Regulation of labeling practices
- Conducting inspections of facilities
- Approving clinical trials
The FDA issues laws in 21 CFR (Code of Federal Regulations). With regards to IVD products, the most prominent divisions of the FDA are:
- Center for Biologics Evaluation and Research (CBER)
- Center for Devices and Radiological Health (CDRH)
