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:
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.
- Manufacturers can use CDRH electronic submissions software (FDA eSubmitter) to prepare reports and correspondence. Alternatively, manufacturers may prepare radiation safety product reports and annual reports using the following:
- Abbreviated Report – provide the information required by Title 21 CFR 1002.12 Abbreviated Reports
- Annual Report – Guide for Preparing Annual Reports on Radiation Safety Testing of Electronic Products (General)
- Compliance Guide for Cabinet X-Ray Systems, September 2007 (Section 2, Definitions, contains information relevant to x-ray and particulate radiation electronic products other than medical diagnostic or cabinet (e.g. analytical, industrial, and medical). Sections 7 and 10 are not product specific and may be useful.)
- Variance Application Process
- Getting a Radiation Emitting Product to Market (April 25, 2006)
- Regulated Industry: Reports and Recordkeeping
- Regulated Industry: Imports & Exports
- Device Advice: Does the Product Emit Radiation? (July 28, 2006)