Reporting for Electronic Products: General Requirements

Reporting and Recordkeeping for Electronic Products - General Requirements

OMB: 0910-0025

IC ID: 5678

Documents and Forms

Document Name Document Type
Form FDA 3626 Reporting for Electronic Products: General Requirements Form and Instruction
FDA 3626 Diagnostic X-Ray 3626 DX Product Report form.pdf Form and Instruction
FDA 3626 Diagnostic X-Ray (esubmitter) 3626 DX Product Report.pdf Form and Instruction
FDA 3627 CT X-Ray 3627 CT Product Report form.pdf Form and Instruction
FDA 3627 CT X-Ray (esubmitter) 3627 CT Product Report.pdf Form and Instruction
FDA 3639 Cabinet X-Ray (esubmitter) 3639 Cabinet X-Ray Product Report.pdf Form and Instruction
FDA 3632 Laser 3632 Laser Product Report form.pdf Form and Instruction
FDA 3632 Laser (esubmitter) 3632 Laser Product Report.pdf Form and Instruction
FDA 3640 Laser Light Show 3640 LLS Report form.pdf Form and Instruction
FDA 3640 Laser Light Show (esubmitter) 3640 LLS Report.pdf Form and Instruction
FDA 3630 Sunlamp 3630 Sunlamp Product Report form.pdf Form and Instruction
FDA 3630 Sunlamp (esubmitter) 3630 Sunlamp Product Report.pdf Form and Instruction
FDA 3646 Mercury vapor lamp (esubmitter) 3646 Mercury Vapor Lamp Product Report.pdf Form and Instruction
FDA 3644 Ultrasonic therapy (esubmitter) 3644 Therapy Ultrasound Product Report.pdf Form and Instruction
FDA 3659 TV (esubmitter) 3659 TV Product Report.pdf Form and Instruction
FDA 3660 Microwave oven (esubmitter) 3660 MWO Product Report.pdf Form and Instruction
FDA 3801 UV lamps 3801 Medical UV Lamp Report form.pdf Form and Instruction
FDA 3629 General abbreviated report (esubmitter) 3629 General Abbreviated Report.pdf Form and Instruction
FDA 3661 X-Ray Report (esubmitter) 3661 Abbrev X-Ray report.pdf Form and Instruction
FDA 3662 Cephalometric Report (esubmitter) 3662 Abbrev Cephalometric report.pdf Form and Instruction
FDA 3663 Microwave products (non-oven) (esubmitter) 3663 Abbrev Microwave report.pdf Form and Instruction
FDA 3628 General Med X-ray annual report (esubmitter) 3628 General Annual Report (includes medical, analytical, industrial x-ray products) .pdf Form and Instruction
FDA 3634 TV annual report (esubmitter) 3634 TV Annual Report.pdf Form and Instruction
FDA 3638 Diagnostic X-ray annual report (esubmitter) 3638 DX Annual Report.pdf Form and Instruction
FDA 3641 Cabinet x-ray annual report (esubmitter) 3641 Cabinet X-Ray Annual Report.pdf Form and Instruction
FDA 3643 MIcrowave oven annual report 3643 MWO Annual Report.pdf Form and Instruction
FDA 3636 Laser annual report (esubmitter) 3636 Laser Annual Report.pdf Form and Instruction
FDA 3631 Sunlamp annual report (esubmitter) 3631 Sunlamp Annual Report.pdf Form and Instruction
FDA 2579 Report of Assembly of a Diagnostic X-Ray System 2579 Assembler Report.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 2877 EPRC Imports form.pdf Form and Instruction
FDA 3649 Accidental Radiation Occurrence Report 3649 ARO Report form .pdf Form and Instruction
FDA 3649 Accidental Radiation Occurrence Report (esubmitter) 3649 ARO Report.pdf Form and Instruction
FDA 3633 General Variance Request (esubmitter) 3633 General Variance Application.pdf Form and Instruction
FDA 3635 Laser Show Notification (esubmitter) 3635 LLS Notification.pdf Form and Instruction
FDA 3637 Original Equipment Manufacturer (OEM) Report (esubmitter 3637 Laser OEM Component Report.pdf Form and Instruction
FDA 3147 Application for a Variance from 21 CFR 1040.11(c) for a 3147 Application for LLS Variance form.pdf Form and Instruction
FDA 3147 Application for a Variance from 21 CFR 1040.11(c) for a 3147 Application for LLS Variance.pdf Form and Instruction
FDA 3642 General Correspondence 3642 General Correspondence.pdf Form and Instruction
FDA 3645 Therapy Ultrasound Annual Report 3645 Therapy Ultrasound Annual Report form.pdf Form and Instruction
FDA 3645 Therapy Ultrasound Annual Report (esubmitter) 3645 Therapy Ultrasound Annual Report.pdf Form and Instruction
FDA 3646 Mercury Vapor Lamp Product Report 3646 Mercury Vapor Lamp Product Report form.pdf Form and Instruction
FDA 3647 Mercury Vapor Lamp Annual Report 3647 Mercury Vapor Lamp Annual Report form.pdf Form and Instruction
FDA 3647 Mercury Vapor Lamp Annual Report (esubmitter) 3647 Mercury Vapor Lamp Annual Report.pdf Form and Instruction
FDA 3636 Laser Annual Report 3636 Laser Annual Report form.pdf Form and Instruction
FDA 3639 Cabinet X-Ray Product Report 3639 Cabinet X-Ray Product Report form.pdf Form and Instruction
FDA 3644 Therapy Ultrasound Product Report 3644 Therapy Ultrasound Product Report form.pdf Form and Instruction
FDA 3660 Microwave oven 3660 MWO Product Report form.pdf Form and Instruction
FDA 3661 X-Ray Report 3661 Abbrev X-Ray report form.pdf Form and Instruction
FDA 3662 Cephalometric Report 3662 Abbrev Cephalometric report form.pdf Form and Instruction
FDA 3663 Microwave products (non-oven) 3663 Abbrev Microwave report form.pdf Form and Instruction