Guide for Preparing Annual Reports on Radiation Safety Testing of Electronic Products (General)

摘要

For manufacturers of electronic products other than those for which a specific guide has been issued, the guide replaces the 'Guide for the Filing of Annual Reports (21 CFR Subchapter J, Section 1002.11)', HHS Publication FDA 82-8127. The electronic product (general) annual reporting guide is applicable to the following products: products intended to produce x radiation (accelerators, analytical devices, therapy x-ray machines); microwave diathermy machines; cold-cathode discharge tubes; and vacuum switches and tubes operating at or above 15,000 volts. To carry out its responsibilities under Public Law 90-602, the Food and Drug Administration's Center for Devices and Radiological Health (CDRH) has issued a series of regulations contained in Title 21 of the Code of Federal Regulations (CFR). Part 1002 of 21 CFR deals with records and reports. Section 1002.61 categorizes electronic products into Groups A through C. Section 1002.30 requires manufacturers of products in Groups B and C to establish and maintain certain records, while Section 1002.11 requires such manufacturers to submit an Annual Report summarizing the contents of the required records. Section 1002.7 requires that reports conform to reporting guides issued by CDRH unless an acceptable justification for an alternate format is provided.