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  1. Classify Your Medical Device

Does the Product Emit Radiation?

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FDA regulates radiation emitting electronic products. The purpose is to prevent unnecessary exposure to radiation due to the use of these products. There are specific requirements that apply to all radiation emitting electronic products in order to comply with the provisions of the Federal Food, Drug and Cosmetic (FD&C) Act. If the product is also a medical device, the product must also comply with the medical device regulations.

Definition of Electronic Product Radiation

Manufacturers and distributors of products meeting the definition of "electronic product radiation" in section 531 of the Federal Food Drug & Cosmetic (FD&C) Act may be subject to certain provisions of the FD&C Act including the retention of records and submission of product reports to the FDA, specifically to the Center for Devices and Radiological Health (CDRH). The FDA requirements for these products, record keeping and reporting, are included in the final regulations contained in Title 21 Code of Federal Regulations Parts 1000-1050 (21 CFR 1000 - 1050). According to section 531 of the FD&C Act:

  1. the term "electronic product radiation" means -
    1. any ionizing or non-ionizing electromagnetic or particulate radiation, or
    2. 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;
  2. the term "electronic product" means
    1. any manufactured or assembled product which, when in operation,
      1. contains or acts as part of an electronic circuit and
      2. emits (or in the absence of effective shielding or other controls would emit) electronic product radiation, or
    2. any manufactured or assembled article which is intended for use as a component, part, or accessory of a product described in clause (A) and which when in operation emits (or in the absence of effective shielding or other controls would emit) such radiation;
  3. the term "manufacturer" means any person engaged in the business of manufacturing, assembling, or importing of electronic products.

Most radiation-emitting products are not considered to be medical devices. However, if you make any medical claims, your product is a medical device also subject to the provisions of the FD&C Act for medical devices in addition to the provisions for radiation emitting products.

Examples of Electronic Products

Examples of radiation emitting electronic products subject to the provisions of the FD&C Act and therefore regulated by FDA are listed in 21 CFR 1000.1 and include:

  1. Ionizing electromagnetic radiation:
    • Television receivers
    • Accelerators
    • X-ray machines (industrial, medical, research, educational)
  2. Particulate radiation and ionizing electromagnetic radiation:
    • Electron microscopes
    • Neutron generators
  3. Ultraviolet:
    • Biochemical and medical analyzers
    • Tanning and therapeutic lamps
    • Sanitizing and sterilizing devices
    • Black light sources
    • Welding equipment
  4. Visible:
    • White light devices
  5. Infrared:
    • Alarm systems
    • Diathermy units
    • Dryers, ovens, and heaters
  6. Microwave:
    • Alarm systems
    • Diathermy units
    • Dryers, ovens, and heaters
    • Medico-biological heaters
    • Microwave power generating devices
    • Radar devices
    • Remote control devices
    • Signal generators
  7. Radio and low frequency:
    • Cauterizers
    • Diathermy units
    • Power generation and transmission equipment
    • Signal generators
    • Electromedical equipment
  8. Laser:
    • Art-form, experimental and educational devices
    • Biomedical analyzers
    • Cauterizing, burning and welding devices
    • Cutting and drilling devices
    • Communications transmitters
    • Range finding devices
  9. Maser:
    • Communications transmitters.
  10. Infrasonic:
    • Vibrators
  11. Sonic:
    • Electronic oscillators
    • Sound amplification equipment
  12. Ultrasonic:
    • Cauterizers
    • Cell and tissue disintegrators
    • Cleaners
    • Diagnostic and nondestructive testing equipment
    • Ranging and detection equipment

Record and Reporting Requirements by Product

Certain radiation emitting products require the submission of product reports to FDA and the retention of records as included in 21 CFR Part 1002 and Table I that follows.

Note: All manufacturers of electronic products are subject to the reporting of accidental radiation occurrences, as required by 21 CFR 1002.20.

Table I - Record and Reporting Requirements By Product

Manufacturer Dealer &
Product Category Products Product
and 1002.41
DIAGNOSTIC X-RAY3 (1020.30, 1020.31, 1020.32, 1020.33) Computed tomography         X X X
X-ray system4         X X X
Tube housing assembly         X X  
X-ray control         X X X
X-ray high voltage generator         X X X
X-ray table or cradle         X X X
X-ray film changer         X X  
Vertical cassette holders mounted in a fixed location and cassette holders with front panels         X X X
Beam-limiting devices         X X X
Spot-film devices and image intensifiers manufactured after April 26, 1977         X X X
Cephalometric devices manufactured after February 25, 1978         X X  
Image receptor support devices for mammographic X-ray systems manufactured after September 5, 1978         X X X
CABINET X-RAY (1020.40) Baggage inspection X X   X X X X
Other X X   X X X  
Analytical     X X X X  
Industrial     X X X X  
TELEVISION PRODUCTS (1020.10) <0.1 milliroentgen="" per="" hour="" (mR/hr="">5,6     X8 X6      
>=0.1mR/hr IRLC5 X8     X X X  
MICROWAVE/RF MW ovens (1030.10) X8     X X X  
MW diathermy     X        
MW heating, drying, security systems     X        
RF sealers, electromagnetic induction and heating equipment, di-electric heaters (2-500 megahertz)     X        
OPTICAL Phototherapy products              
Laser products (1040.10,  1040.11) Class I lasers and products containing lasers7,9 X8     X X    
Class I laser products containing class IIa, II, IIIa, lasers7,9 X     X X X  
Class IIa, II, IIIa lasers and products other than class I products containing such lasers7,9 X     X X X
Class IIIb and IV lasers and products containing such lasers7 X X   X X X X
Sunlamp products (1040.20) Lamps only X            
Sunlamp products X X   X X X X
Mercury vapor lamps (1040.30) R and T lamps     X        

1However, authority to inspect all appropriate documents supporting the adequacy of a manufacturer's compliance testing program is retained.
2The requirement includes 1002.31 and 1002.42, if applicable.
3Report of Assembly (Form FDA 2579) is required for diagnostic x-ray components; see 21 CFR 1020.30(d)(1) through (d)(3).
4Systems records and reports are required if a manufacturer exercises the option and certifies the system as permitted in 21 CFR 1020.30(c).
5Determined using the isoexposure rate limit curve (IRLC) under phase III test conditions (1020.10(c)(3)(iii)).
6Annual report is for production status information only.
7Determination of the applicable reporting category for a laser product shall be based on the worst-case hazard present within the laser product.
8Manufacturers are exempt from product reports (§ 1002.10) and abbreviated reports (§ 1002.12), except the first product or abbreviated report for each category of: television products; microwave ovens; and products that are Class I laser under any condition of operation, maintenance, service, or failure (e.g., Class I optical disc products, laser printers).
9Manufacturers that incorporate a certified laser system meeting the conditions of 21 CFR 1010.2(e) are considered distributors of the certified laser and only subject to the applicable distribution recordkeeping requirements under §§ 1002.40 and 1002.41 for the certified products.

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