FDA Home Page | CDRH Home Page | Search | A-Z Index | ||
|
||||
|
||||
|
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 Food, Drug and Cosmetic Act. If the product is also a medical device, the product must also comply with the medical device regulations.
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 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 Food and Drug Administration (FDA) requirements for these products, record keeping and reporting, are included in the final regulations contained in Title 21 Code of Federal Regulations Parts 1000-1299 (21 CFR 1000- 1299). According to section 531 of the FD&C Act:
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 radiation emitting electronic products subject to the provisions of the FD&C Act and therefore regulated by FDA are listed in 21 CFR 1000.15 and include:
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 occurances, as required by 21 CFR 1002.20.
Table I
Record and Reporting Requirements By Product
Manufacturer |
Dealer & Distributor |
|||||||
---|---|---|---|---|---|---|---|---|
Product Category | Products | |||||||
DIAGNOSTIC X-RAY3 (1020.30 , 1020.31, 1020.32, 1020.33) | Computed tomography |
X |
X |
|
X |
X |
X |
X |
X-ray system4 |
X |
X |
|
X |
X |
X |
X |
|
Tube housing assembly |
X |
X |
|
X |
X |
X |
|
|
X-ray control |
X |
X |
|
X |
X |
X |
X |
|
X-ray high voltage generator |
X |
X |
|
X |
X |
X |
X |
|
X-ray table or cradle |
|
|
X |
|
X |
X |
X |
|
X-ray film changer |
|
|
X |
|
X |
X |
|
|
Vertical cassette holders mounted in a fixed location and cassette holders with front panels |
|
|
X |
|
X |
X |
X |
|
Beam-limiting devices |
X |
X |
|
X |
X |
X |
X |
|
Spot-film devices and image intensifiers manufactured after April 26, 1977 |
X |
X |
|
X |
X |
X |
X |
|
Cephalometric devices manufactured after February 25, 1978 |
|
|
X |
|
X |
X |
|
|
Image receptor support devices for mammographic X-ray systems manufactured after September 5, 1978 |
|
|
X |
|
X |
X |
X |
|
CABINET X-RAY (1020.40) | Baggage inspection |
X |
X |
|
X |
X |
X |
X |
Other |
X |
X |
|
X |
X |
X |
|
|
PRODUCTS INTENDED TO PRODUCE PARTICULATE RADIATION OR X-RAYS OTHER THAN DIAGNOSTIC OR CABINET DIAGNOSTIC X-RAY | Medical |
|
|
X |
X |
X |
X |
|
Analytical |
|
|
X |
X |
X |
X |
|
|
Industrial |
|
|
X |
X |
X |
X |
|
|
TELEVISION PRODUCTS (1020.10) | <25 kilovolt (kV) and <0.1 milliroentgen per hour (mR/hr IRLC5,6 |
|
|
X |
X6 |
|
|
|
>25kV and <0.1mR/hr IRLC5 |
X |
X |
|
X |
|
|
|
|
>0.1mR/hr IRLC5 |
X |
X |
|
X |
X |
X |
|
|
MICROWAVE/RF | MW ovens (1030.10) |
X |
X |
|
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 |
X |
X |
|
|
|
|
|
Laser products (1040.10, 1040.11) | Class I lasers and products containing lasers7 |
X |
|
|
X |
X |
|
|
Class I laser products containing class IIa, II, IIIa, lasers7 |
X |
|
|
X |
X |
X |
|
|
Class IIa, II, IIIa lasers and products other than class I products containing such lasers7 |
X |
X |
|
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) | T lamps |
|
X |
X |
|
X |
|
|
R lamps |
|
|
|
X |
|
|
|
|
ACOUSTIC |
|
|
|
|
|
|
|
|
Ultrasonic therapy(1050.10) |
X |
X |
|
X |
X |
X |
X |
|
Diagnostic ultrasound |
|
X |
|
|
|
|
||
Medical ultrasound other than therapy or diagnostic |
X |
X |
|
|
|
|
|
|
Non-medical ultrasound |
|
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.
Please note that there are additional requirements for radiation emitting product that are also medical devices.
Labeling requirements for radiation emitting products are also available.
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH