Laws and Regulations (Radiation-Emitting Products)

The Radiation Control provisions (originally enacted as the Radiation Control for Health and Safety Act of 1968) are located in Sections 531 through 542 of the Act. They 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.

"Electronic product radiation" is defined as:

(A) any ionizing or non-ionizing electromagnetic or particulate radiation, or

(B) any sonic, infrasonic, or ultrasonic wave, which is emitted from an electronic product as the result of the operation of an electronic circuit in such product.

Examples of electronic products: Medical: diagnostic x-ray or ultrasound imaging devices, microwave or ultrasound diathermy devices, microwave blood warmers or sterilizers, laser coagulators, ultrasound phacoemulsifiers, x-ray or electron accelerators, sunlamps, ultraviolet dental curing devices; Non-medical: microwave ovens, televisions receivers and monitors (video displays), entertainment lasers, industrial x-ray systems, cordless and cellular telephones, industrial RF sealers of plastics and laminates, laser CD players.

• Radiation Control Law (Federal FD&C Act)
• Overview of Laws and Regulations
• Summary of Electronic Product Radiation Control Provisions
• Code of Federal Regulations Title 21, Subchapter J (Radiological Health)
• General Requirements for All Electronic Products which Emit Radiation (21 CFR § 1000 - 1005)
• Overlap of FDA Enforcement Authorities for Radiation Emitting Products [PDF]

 

Subchapter C: Electronic Product Radiation Control

• SEC. 531. [21 USC §360hh] Definitions
• SEC. 532. [21 USC §360ii] Electronic Product Radiation Control Program
• SEC. 533. [21 USC §360jj] Studies by the Secretary
• SEC. 534. [21 USC §360kk] Performance Standards for Electronic Products
• SEC. 535. [21 USC §360ll] Notification of Defects in, and Repair or Replacement of, Electronic Products
• SEC. 536. [21 USC §360mm] Imports
• SEC. 537. [21 USC §360nn] Inspection and Reports
• SEC. 538. [21 USC §360oo] Prohibited Acts
• SEC. 539. [21 USC §360pp] Enforcement
• SEC. 541. [21 USC §360rr] Federal-State Cooperation
• SEC. 542. [21 USC §360ss] Effect on State Standards

Resources For You

• Performance Standards: Radiological Health Program
• Center for Devices and Radiological Health (CDRH) Compliance Program