Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

        Electronic Product Radiation Control Program

Laws and Regulations (Radiation-Emitting Products) Home
          Radiation-Emitting Products
          Electronic Product Radiation Control Program
          Laws and Regulations (Radiation-Emitting Products)Electronic Product Radiation Control Program Laws and Regulations (Radiation-Emitting Products)
  	
        Share
    Post
    Linkedin

    Email
    PrintThe Radiation Control provisions (originally enacted as the Radiation Control for Health and Safety Act of 1968) are located in Sections 531 through 542 of the Act.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 StandardsResources For You

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

                                                                                  Content current as of:
      09/03/2020Laws and Regulations (Radiation-Emitting Products)
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop