FDA Radiological Health Program
The mission of the FDA’s radiological health program is to protect the public from hazardous or unnecessary radiation exposure from radiation-emitting electronic products.
FDA’s Center for Devices and Radiological Health (CDRH) does this by:
- Regulating radiation-emitting electronic products used for both medical and non-medical applications, under the authorities of the Electronic Product Radiation Control provisions and the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act;
- Regulating facilities that perform mammography under the authority of the Mammography Quality Standards Act; and
- Assisting in the protection of the public by supporting FDA’s radiation emergency response activities.
The program works with a wide range of stakeholders including States and other Federal agencies, professional organizations, academic institutions, users, manufacturers, and consumer groups.
To accomplish the mission of the radiological health program, CDRH:
- Maintains awareness of new and existing radiation-emitting products, their manner of use, and their manufacturers;
- Studies the biological effects of radiation-emitting products and their potential risks to health;
- Assesses radiation emission levels from products in various applications;
- Provides direction and guidance to the general public and users of radiation-emitting products to minimize unnecessary radiation exposure; and
- Oversees product manufacturer compliance with all applicable requirements and pursues regulatory and enforcement action to address public health problems.
This page provides links to various segments of the Radiological Health Program.