Radiation-Emitting Products

X-Ray & Particulate Products other than Medical Diagnostic or Cabinet

Introduction: Laws, Regulations & Standards

Manufacturers of electronic radiation emitting products sold in the United States are responsible for compliance with the Federal Food, Drug and Cosmetic Act (FFDCA), Chapter V, Subchapter C - Electronic Product Radiation Control.

Manufacturers of electronic products that emit x-ray or particulate radiation, other than medical diagnostic or cabinet, are responsible for compliance with all applicable requirements of Title 21 Code of Federal Regulations (Subchapter J, Radiological Health) Parts 1000 through 1004 and 1005.25:

1000 - General

1002 - Records and Reports

1003 - Notification of defects or failure to comply

1004 - Repurchase, repairs, or replacement of electronic products

1005.25 - Importation of electronic products, Service of process on manufacturers

Use of electronic products that emit ionizing radiation is regulated either by the U.S. Occupational Safety & Health Administration or by State Government.

Additionally, voluntary radiation safety consensus standards may be available for your product.  American National Standards Institute (ANSI) / Health Physics Society (HPS) N43 standards apply to radiation protection aspects of radiation-producing equipment used in industrial and non-medical research and development activities (excluding nuclear reactors).

When these products are intended for medical applications they must also comply with the medical device regulations. For more information, see Getting to Market with a Medical Device.

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Industry Guidance

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Page Last Updated: 03/07/2018
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