Electronic Product Radiation Control Program
FDA is responsible for regulating radiation-emitting electronic products. The agency's goal is to protect the public from hazardous and unnecessary exposure to radiation from electronic products.
The Radiation Control provisions apply to any "electronic product" which is defined as any manufactured or assembled product (or component, part, or accessory of such product) which, when in operation
(i) contains or acts as part of an electronic circuit and
(ii) emits (or in the absence of effective shielding or other controls would emit) electronic product radiation.
Examples of electronic products:
Medical: diagnostic x-ray or ultrasound imaging devices, microwave or ultrasound diathermy devices
Non-medical: microwave ovens, televisions receivers and monitors (video displays), entertainment lasers
Tools
- FDA eSubmitter
- Getting a Radiation Emitting Product to Market
- Alerts and Notices
- Report a Problem
- Facility Certification and Inspection (MQSA)
- Medical Device Databases
- CDRH Ombudsman
Resources For You
- Radiation-Emitting Products Industry Assistance: Walk-through
- Submitting Reports and Requirements for Maintaining Records for Radiation
- Importing and Exporting Electronic Products
- Performance Standards: Radiological Health Program