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 Diagnos 3626 DX Product Report form.pdf Form and Instruction
FDA 3626 A Guide for the Submission of Initial Reports on Diagnos 3626 DX Product Report form.pdf Form and Instruction
FDA 3627 A Guide for the Submission of Initial Reports on Compute 3627 CT Product Report form.pdf Form and Instruction
FDA 3627 A Guide for the Submission of Initial Reports on Compute 3627 CT Product Report form.pdf Form and Instruction
FDA 3639 Guidance for the Submission of Cabinet X-Ray System Repo 3639 Cabinet X-Ray Product Report form.pdf Form and Instruction
FDA 3639 Guidance for the Submission of Cabinet X-Ray System Repo 3639 Cabinet X-Ray Product Report form.pdf Form and Instruction
FDA 3632 Guide for Preparing Product Reports for Lasers and Produ 3632 Laser Product Report form.pdf Form and Instruction
FDA 3632 Guide for Preparing Product Reports for Lasers and Produ 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 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 Sunl 3630 Sunlamp Product Report form.pdf Form and Instruction
FDA 3630 Guide for Preparing Product Reports on Sunlamps and Sunl 3630 Sunlamp Product Report form.pdf Form and Instruction
FDA 3644 Guide for Preparing Product Reports for Ultrasonic Thera 3644 Therapy Ultrasound Product Report form.pdf Form and Instruction
FDA 3644 Guide for Preparing Product Reports for Ultrasonic Thera 3644 Therapy Ultrasound Product Report form.pdf Form and Instruction
FDA 3659 TV Product Report 3659 TV Product Report.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 Mi 3660 MWO Product Report form.pdf Form and Instruction
FDA 3660 Guidance for Preparing Reports on Radiation Safety of Mi 3660 MWO Product Report form.pdf Form and Instruction
FDA 3801 Guide for Preparing Initial Reports and Model Change Rep 3801 Medical UV Lamp Report form.pdf Form and Instruction
FDA 3801 Guide for Preparing Initial Reports and Model Change Rep 3801 Medical UV Lamp Report form.pdf Form and Instruction
FDA 3629 General Abbreviated Report 3629 General Abbreviated Report.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 3661 Abbrev X-Ray report form.pdf Form and Instruction
FDA 3661 A Guide for the Submission of an Abbreviated Report on X 3661 Abbrev X-Ray report form.pdf Form and Instruction
FDA 3662 A Guide for the Submission of an Abbreviated Radiation S 3662 Abbrev Cephalometric report form.pdf Form and Instruction
FDA 3662 A Guide for the Submission of an Abbreviated Radiation S 3662 Abbrev Cephalometric report form.pdf Form and Instruction
FDA 3663 Abbreviated Reports on Radiation Safety for Microwave Pr 3663 Abbrev Microwave report form.pdf Form and Instruction
FDA 3663 Abbreviated Reports on Radiation Safety for Microwave Pr 3663 Abbrev Microwave report form.pdf Form and Instruction
FDA 3628 Guide for Preparing Annual Reports on Radiation Safety T 3628 General Annual Report (includes medical, analytical, industrial x-ray products) form.pdf Form and Instruction
FDA 3628 Guide for Preparing Annual Reports on Radiation Safety T 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 3634 TV Annual Report 3634 TV Annual Report.pdf Form and Instruction
FDA 3638 Guide for Filing Annual Reports for X-Ray Components and 3638 DX Annual Report form.pdf Form and Instruction
FDA 3638 Guide for Filing Annual Reports for X-Ray Components and 3638 DX Annual Report form.pdf Form and Instruction
FDA 3641 Guide for Filing Annual Reports for X-Ray Components and 3641 Cabinet X-Ray Annual Report form.pdf Form and Instruction
FDA 3641 Guide for Filing Annual Reports for X-Ray Components and 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 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 T 3636 Laser Annual Report form.pdf Form and Instruction
FDA 3636 Guide for Preparing Annual Reports on Radiation Safety T 3636 Laser Annual Report form.pdf Form and Instruction
FDA 3631 Guide for Preparing Annual Reports on Radiation Safety T 3631 Sunlamp Annual Report form.pdf Form and Instruction
FDA 3631 Guide for Preparing Annual Reports on Radiation Safety T 3631 Sunlamp Annual Report form.pdf Form and Instruction
FDA 3647 Guide for Preparing Annual Reports on Radiation Safety T 3647 Mercury Vapor Lamp Annual Report form.pdf Form and Instruction
FDA 3647 Guide for Preparing Annual Reports on Radiation Safety T 3647 Mercury Vapor Lamp Annual Report form.pdf Form and Instruction
FDA 3645 Guide for Preparing Annual Reports for Ultrasonic Therap 3645 Therapy Ultrasound Annual Report form.pdf Form and Instruction
FDA 3645 Guide for Preparing Annual Reports for Ultrasonic Therap 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 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 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 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 2877 Declaration for Imported Electronic Products Subject to 2877 EPRC Imports form.pdf Form and Instruction
FDA 3633 General Variance Application 3633 General Variance Application.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 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 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
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
3646 Mercury Vapor Lamp Products Radiation Safety Report FDA-3646_09-23-20-update.pdf Form

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	Reporting for Electronic Products	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Unchanged

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 1010 Prfm Stds/General 21 CFR 1020 Prfm Stds/Ion-Radiation 21 CFR 1030 Prfm Stds/Microwave 21 CFR 1005 Importation 21 CFR 1040 Prfm Stds/Light Emitting 21 CFR 1000 General Provisions 21 CFR 1002 Records and Reports 21 CFR 1003 Notifications 21 CFR 1004 Repurchase/repair/replace 21 CFR 1050 Prfm Stds Ultrasound

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
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	Yes	Yes	Fillable Fileable
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	Yes	Yes	Fillable Fileable
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	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3632	Guide for Preparing Product Reports for Lasers and Products Containing Lasers	3632 Laser Product Report form.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3640	Reporting Guide for Laser Light Shows and Displays	3640 LLS Report form.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3630	Guide for Preparing Product Reports on Sunlamps and Sunlamp Products	3630 Sunlamp Product Report form.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3644	Guide for Preparing Product Reports for Ultrasonic Therapy Products	3644 Therapy Ultrasound Product Report form.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3659	TV Product Report	3659 TV Product Report.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3660	Guidance for Preparing Reports on Radiation Safety of Microwave Ovens	3660 MWO Product Report form.pdf	Yes	Yes	Fillable Fileable
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	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3629	General Abbreviated Report	3629 General Abbreviated Report.pdf	Yes	Yes	Fillable Fileable
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	Yes	Yes	Fillable Fileable
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	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3663	Abbreviated Reports on Radiation Safety for Microwave Products (Other than Microwave Ovens)	3663 Abbrev Microwave report form.pdf	Yes	Yes	Fillable Fileable
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	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3634	TV Annual Report	3634 TV Annual Report.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3638	Guide for Filing Annual Reports for X-Ray Components and Systems	3638 DX Annual Report form.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3641	Guide for Filing Annual Reports for X-Ray Components and Systems	3641 Cabinet X-Ray Annual Report form.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3643	Microwave Oven Products Annual Report	3643 MWO Annual Report form.pdf	Yes	Yes	Fillable Fileable
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	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3631	Guide for Preparing Annual Reports on Radiation Safety Testing of Sunlamp Products	3631 Sunlamp Annual Report form.pdf	Yes	Yes	Fillable Fileable
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	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3645	Guide for Preparing Annual Reports for Ultrasonic Therapy Products	3645 Therapy Ultrasound Annual Report form.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3649	Accidental Radiation Occurrence Report	3649 ARO Report form .pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3642	General Correspondence	3642 General Correspondence.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 2767	Notice of Availability of Sample Electronic Product	2767 Sample Availability form.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 2877	Declaration for Imported Electronic Products Subject to Radiation Control Standards	2877 EPRC Imports form.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3633	General Variance Application	3633 General Variance Application.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3635	LLS Notification	3635 LLS Notification.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3637	Laser OEM Component Report	3637 Laser OEM Component Report.pdf	Yes	Yes	Fillable Fileable
Form	FDA 2579	REPORT OF ASSEMBLY OF A DIAGNOSTIC X-RAY SYSTEM	FDA-2579_Stat_Sec_Ext_12-12-22.pdf	Yes	Yes	Fillable Fileable
Form	3646	Mercury Vapor Lamp Products Radiation Safety Report	FDA-3646_09-23-20-update.pdf	Yes	Yes	Fillable Fileable

Federal Enterprise Architecture Business Reference Module

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 16,181	Number of Respondents for Small Entity: 1,000

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 50 %

	Approved	Previously Approved
Annual Number of Responses for this IC	38,012	38,012
Annual IC Time Burden (Hours)	102,744	102,744
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

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Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.