Electronic Products Requirements
OMB 0910-0025
To protect the public from unnecessary exposure to radiation from electronic products, FDA must collect certain information from manufacturers and dealers/distributors about electronic products they sell or install. This ICR collects information from electronic product and x-ray manufacturers, importers, and assemblers. These respondents report and maintain information related to the identification of, location of, operational characteristics of, quality assurance programs for, and problem identification and correction of electronic products. The data reported to the Food and Drug Administration (FDA) and the records maintained are used by FDA and industry to make decisions and take actions that protect the public from radiation hazards presented by electronic products. The information collections are either specifically called for in legislation or were developed to aid FDA in performing its obligations under legislation.
The latest form for Electronic Products Requirements expires 2023-08-31 and can be found here.
0025 Electronic Products RIN AH65 SSA 2023.docx
Reporting for Electronic Products Reporting for Electronic Products
Federal Enterprise Architecture: Health - Consumer Health and Safety
| Form FDA 3659 | TV Product Report | Fillable Fileable | Form and instruction |
| Form FDA 2579 | Report of Assembly of a Diagnostic X-Ray System | Fillable Fileable | Form and instruction |
| Form FDA 3642 | General Correspondence | Fillable Fileable | Form and instruction |
| Form FDA 3637 | Laser OEM Component Report | Fillable Fileable | Form and instruction |
| Form FDA 3635 | LLS Notification | Fillable Fileable | Form and instruction |
| Form FDA 3633 | General Variance Application | Fillable Fileable | Form and instruction |
| Form FDA 2877 | Declaration for Imported Electronic Products Subject to Radiation Control Standards | Fillable Fileable | Form and instruction |
| Form FDA 2767 | Notice of Availability of Sample Electronic Product | Fillable Fileable | Form and instruction |
| Form FDA 3649 | Accidental Radiation Occurrence Report | Fillable Fileable | Form and instruction |
| Form FDA 3647 | Guide for Preparing Annual Reports on Radiation Safety Testing of Mercury Vapor Lamps | Fillable Fileable | Form and instruction |
| Form FDA 3631 | Guide for Preparing Annual Reports on Radiation Safety Testing of Sunlamp Products | Fillable Fileable | Form and instruction |
| Form FDA 3636 | Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show Products | Fillable Fileable | Form and instruction |
| Form FDA 3643 | Microwave Oven Products Annual Report | Fillable Fileable | Form and instruction |
| Form FDA 3641 | Guide for Filing Annual Reports for X-Ray Components and Systems | Fillable Fileable | Form and instruction |
| Form FDA 3638 | Guide for Filing Annual Reports for X-Ray Components and Systems | Fillable Fileable | Form and instruction |
| Form FDA 3634 | TV Annual Report | Fillable Fileable | Form and instruction |
| Form FDA 3628 | Guide for Preparing Annual Reports on Radiation Safety Testing of Electronic Products (General) | Fillable Fileable | Form and instruction |
| Form FDA 3663 | Abbreviated Reports on Radiation Safety for Microwave Products (Other than Microwave Ovens) | Fillable Fileable | Form and instruction |
| Form FDA 3662 | A Guide for the Submission of an Abbreviated Radiation Safety Report on Cephalometric Devices Intended for Diagnostic Use | Fillable Fileable | Form and instruction |
| Form FDA 3801 | Guide for Preparing Initial Reports and Model Change Reports on Medical Ultraviolet Lamps and Products Containing Such Lamps | Fillable Fileable | Form and instruction |
| Form FDA 3661 | A Guide for the Submission of an Abbreviated Report on X-Ray Tables, Cradles, Film Changers or Cassette Holders Intended for Diagnostic Use | Fillable Fileable | Form and instruction |
| Form FDA 3629 | General Abbreviated Report | Fillable Fileable | Form and instruction |
| Form FDA 3660 | Guidance for Preparing Reports on Radiation Safety of Microwave Ovens | Fillable Fileable | Form and instruction |
| Form FDA 3632 | Guide for Preparing Product Reports for Lasers and Products Containing Lasers | Fillable Fileable | Form and instruction |
| Form FDA 3639 | Guidance for the Submission of Cabinet X-Ray System Reports Pursuant to 21 CFR 1020.40 | Fillable Fileable | Form and instruction |
| Form FDA 3627 | A Guide for the Submission of Initial Reports on Computed Tomography X-Ray Systems | Fillable Fileable | Form and instruction |
| Form FDA 3626 | A Guide for the Submission of Initial Reports on Diagnostic X-Ray Systems and Their Major Components | Fillable Fileable | Form and instruction |
| Form FDA 3630 | Guide for Preparing Product Reports on Sunlamps and Sunlamp Products | Fillable Fileable | Form and instruction |
| Form FDA 3640 | Reporting Guide for Laser Light Shows and Displays | Fillable Fileable | Form and instruction |
| Form FDA 3644 | Guide for Preparing Product Reports for Ultrasonic Therapy Products | Fillable Fileable | Form and instruction |
| Form FDA 3646 | Mercury Vapor Lamp Products Radiation Safety Report | Fillable Fileable | Form and instruction |
| Form FDA 3645 | Guide for Preparing Annual Reports for Ultrasonic Therapy Products | Fillable Fileable | Form and instruction |
Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.
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