Reporting for Electronic Products

Electronic Products Requirements

OMB: 0910-0025

IC ID: 5678

Documents and Forms

Document Name Document Type
Form FDA 3626 Reporting for Electronic Products Form and Instruction
FDA 3626 A Guide for the Submission of Initial Reports on Diagnostic X-Ray Systems and Their Major Components 3626 DX Product Report form.pdf Form and Instruction
FDA 3627 A Guide for the Submission of Initial Reports on Computed Tomography X-Ray Systems 3627 CT Product Report form.pdf Form and Instruction
FDA 3639 Guidance for the Submission of Cabinet X-Ray System Reports Pursuant to 21 CFR 1020.40 3639 Cabinet X-Ray Product Report form.pdf Form and Instruction
FDA 3632 Guide for Preparing Product Reports for Lasers and Products Containing Lasers 3632 Laser Product Report form.pdf Form and Instruction
FDA 3640 Reporting Guide for Laser Light Shows and Displays 3640 LLS Report form.pdf Form and Instruction
FDA 3630 Guide for Preparing Product Reports on Sunlamps and Sunlamp Products 3630 Sunlamp Product Report form.pdf Form and Instruction
FDA 3644 Guide for Preparing Product Reports for Ultrasonic Therapy Products 3644 Therapy Ultrasound Product Report form.pdf Form and Instruction
FDA 3659 TV Product Report 3659 TV Product Report.pdf Form and Instruction
FDA 3660 Guidance for Preparing Reports on Radiation Safety of Microwave Ovens 3660 MWO Product Report form.pdf Form and Instruction
FDA 3801 Guide for Preparing Initial Reports and Model Change Reports on Medical Ultraviolet Lamps and Products Containing Such Lamps 3801 Medical UV Lamp Report form.pdf Form and Instruction
FDA 3629 General Abbreviated Report 3629 General Abbreviated Report.pdf Form and Instruction
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 3661 Abbrev X-Ray report form.pdf Form and Instruction
FDA 3662 A Guide for the Submission of an Abbreviated Radiation Safety Report on Cephalometric Devices Intended for Diagnostic Use 3662 Abbrev Cephalometric report form.pdf Form and Instruction
FDA 3663 Abbreviated Reports on Radiation Safety for Microwave Products (Other than Microwave Ovens) 3663 Abbrev Microwave report form.pdf Form and Instruction
FDA 3628 Guide for Preparing Annual Reports on Radiation Safety Testing of Electronic Products (General) 3628 General Annual Report (includes medical, analytical, industrial x-ray products) form.pdf Form and Instruction
FDA 3634 TV Annual Report 3634 TV Annual Report.pdf Form and Instruction
FDA 3638 Guide for Filing Annual Reports for X-Ray Components and Systems 3638 DX Annual Report form.pdf Form and Instruction
FDA 3641 Guide for Filing Annual Reports for X-Ray Components and Systems 3641 Cabinet X-Ray Annual Report form.pdf Form and Instruction
FDA 3643 Microwave Oven Products Annual Report 3643 MWO Annual Report form.pdf Form and Instruction
FDA 3636 Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show Products 3636 Laser Annual Report form.pdf Form and Instruction
FDA 3631 Guide for Preparing Annual Reports on Radiation Safety Testing of Sunlamp Products 3631 Sunlamp Annual Report form.pdf Form and Instruction
FDA 3647 Guide for Preparing Annual Reports on Radiation Safety Testing of Mercury Vapor Lamps 3647 Mercury Vapor Lamp Annual Report form.pdf Form and Instruction
FDA 3645 Guide for Preparing Annual Reports for Ultrasonic Therapy Products 3645 Therapy Ultrasound Annual Report form.pdf Form and Instruction
FDA 3649 Accidental Radiation Occurrence Report 3649 ARO Report form .pdf Form and Instruction
FDA 3642 General Correspondence 3642 General Correspondence.pdf Form and Instruction
FDA 2767 Notice of Availability of Sample Electronic Product 2767 Sample Availability form.pdf Form and Instruction
FDA 2877 Declaration for Imported Electronic Products Subject to Radiation Control Standards 2877 EPRC Imports form.pdf Form and Instruction
FDA 3633 General Variance Application 3633 General Variance Application.pdf Form and Instruction
FDA 3635 LLS Notification 3635 LLS Notification.pdf Form and Instruction
FDA 3637 Laser OEM Component Report 3637 Laser OEM Component Report.pdf Form and Instruction
FDA 2579 REPORT OF ASSEMBLY OF A DIAGNOSTIC X-RAY SYSTEM FDA-2579_Stat_Sec_Ext_12-12-22.pdf Form
3646 Mercury Vapor Lamp Products Radiation Safety Report FDA-3646_09-23-20-update.pdf Form