Information Collection

Reporting for Electronic Products

IC 5678 under ICR 202505-0910-012 · OMB 0910-0025.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form FDA 3626 A Guide for the Submission of Initial Reports on Diagnostic X-Ray Systems and Their Major Components Reporting for Electronic Products	Form and Instruction
Form FDA 3626 A Guide for the Submission of Initial Reports on Diagnostic X-Ray Systems and Their Major Components Reporting for Electronic Products	Form and Instruction
Form FDA 3627 A Guide for the Submission of Initial Reports on Computed Tomography X-Ray Systems Reporting for Electronic Products	Form and Instruction
Form FDA 3627 A Guide for the Submission of Initial Reports on Computed Tomography X-Ray Systems Reporting for Electronic Products	Form and Instruction
Form FDA 3639 Guidance for the Submission of Cabinet X-Ray System Reports Pursuant to 21 CFR 1020.40 Reporting for Electronic Products	Form and Instruction
Form FDA 3639 Guidance for the Submission of Cabinet X-Ray System Reports Pursuant to 21 CFR 1020.40 Reporting for Electronic Products	Form and Instruction
Form FDA 3632 Guide for Preparing Product Reports for Lasers and Products Containing Lasers Reporting for Electronic Products	Form and Instruction
Form FDA 3632 Guide for Preparing Product Reports for Lasers and Products Containing Lasers Reporting for Electronic Products	Form and Instruction
Form FDA 3640 Reporting Guide for Laser Light Shows and Displays Reporting for Electronic Products	Form and Instruction
Form FDA 3640 Reporting Guide for Laser Light Shows and Displays Reporting for Electronic Products	Form and Instruction
Form FDA 3630 Guide for Preparing Product Reports on Sunlamps and Sunlamp Products Reporting for Electronic Products	Form and Instruction
Form FDA 3630 Guide for Preparing Product Reports on Sunlamps and Sunlamp Products Reporting for Electronic Products	Form and Instruction
Form FDA 3644 Guide for Preparing Product Reports for Ultrasonic Therapy Products Reporting for Electronic Products	Form and Instruction
Form FDA 3644 Guide for Preparing Product Reports for Ultrasonic Therapy Products Reporting for Electronic Products	Form and Instruction
Form FDA 3659 TV Product Report Reporting for Electronic Products	Form and Instruction
Form FDA 3659 TV Product Report Reporting for Electronic Products	Form and Instruction
Form FDA 3660 Guidance for Preparing Reports on Radiation Safety of Microwave Ovens Reporting for Electronic Products	Form and Instruction
Form FDA 3660 Guidance for Preparing Reports on Radiation Safety of Microwave Ovens Reporting for Electronic Products	Form and Instruction
Form FDA 3801 Guide for Preparing Initial Reports and Model Change Reports on Medical Ultraviolet Lamps and Products Containing Such Lamps Reporting for Electronic Products	Form and Instruction
Form FDA 3801 Guide for Preparing Initial Reports and Model Change Reports on Medical Ultraviolet Lamps and Products Containing Such Lamps Reporting for Electronic Products	Form and Instruction
Form FDA 3629 General Abbreviated Report Reporting for Electronic Products	Form and Instruction
Form FDA 3629 General Abbreviated Report Reporting for Electronic Products	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 Reporting for Electronic Products	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 Reporting for Electronic Products	Form and Instruction
Form FDA 3662 A Guide for the Submission of an Abbreviated Radiation Safety Report on Cephalometric Devices Intended for Diagnostic Use Reporting for Electronic Products	Form and Instruction
Form FDA 3662 A Guide for the Submission of an Abbreviated Radiation Safety Report on Cephalometric Devices Intended for Diagnostic Use Reporting for Electronic Products	Form and Instruction
Form FDA 3663 Abbreviated Reports on Radiation Safety for Microwave Products (Other than Microwave Ovens) Reporting for Electronic Products	Form and Instruction
Form FDA 3663 Abbreviated Reports on Radiation Safety for Microwave Products (Other than Microwave Ovens) Reporting for Electronic Products	Form and Instruction
Form FDA 3628 Guide for Preparing Annual Reports on Radiation Safety Testing of Electronic Products (General) Reporting for Electronic Products	Form and Instruction
Form FDA 3628 Guide for Preparing Annual Reports on Radiation Safety Testing of Electronic Products (General) Reporting for Electronic Products	Form and Instruction
Form FDA 3634 TV Annual Report Reporting for Electronic Products	Form and Instruction
Form FDA 3634 TV Annual Report Reporting for Electronic Products	Form and Instruction
Form FDA 3638 Guide for Filing Annual Reports for X-Ray Components and Systems Reporting for Electronic Products	Form and Instruction
Form FDA 3638 Guide for Filing Annual Reports for X-Ray Components and Systems Reporting for Electronic Products	Form and Instruction
Form FDA 3641 Guide for Filing Annual Reports for X-Ray Components and Systems Reporting for Electronic Products	Form and Instruction
Form FDA 3641 Guide for Filing Annual Reports for X-Ray Components and Systems Reporting for Electronic Products	Form and Instruction
Form FDA 3643 Microwave Oven Products Annual Report Reporting for Electronic Products	Form and Instruction
Form FDA 3643 Microwave Oven Products Annual Report Reporting for Electronic Products	Form and Instruction
Form FDA 3636 Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show Products Reporting for Electronic Products	Form and Instruction
Form FDA 3636 Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show Products Reporting for Electronic Products	Form and Instruction
Form FDA 3631 Guide for Preparing Annual Reports on Radiation Safety Testing of Sunlamp Products Reporting for Electronic Products	Form and Instruction
Form FDA 3631 Guide for Preparing Annual Reports on Radiation Safety Testing of Sunlamp Products Reporting for Electronic Products	Form and Instruction
Form FDA 3647 Guide for Preparing Annual Reports on Radiation Safety Testing of Mercury Vapor Lamps Reporting for Electronic Products	Form and Instruction
Form FDA 3647 Guide for Preparing Annual Reports on Radiation Safety Testing of Mercury Vapor Lamps Reporting for Electronic Products	Form and Instruction
Form FDA 3645 Guide for Preparing Annual Reports for Ultrasonic Therapy Products Reporting for Electronic Products	Form and Instruction
Form FDA 3645 Guide for Preparing Annual Reports for Ultrasonic Therapy Products Reporting for Electronic Products	Form and Instruction
Form FDA 3649 Accidental Radiation Occurrence Report Reporting for Electronic Products	Form and Instruction
Form FDA 3649 Accidental Radiation Occurrence Report Reporting for Electronic Products	Form and Instruction
Form FDA 3642 General Correspondence Reporting for Electronic Products	Form and Instruction
Form FDA 3642 General Correspondence Reporting for Electronic Products	Form and Instruction
Form FDA 2767 Notice of Availability of Sample Electronic Product Reporting for Electronic Products	Form and Instruction
Form FDA 2767 Notice of Availability of Sample Electronic Product Reporting for Electronic Products	Form and Instruction
Form FDA 2877 Declaration for Imported Electronic Products Subject to Radiation Control Standards Reporting for Electronic Products	Form and Instruction
Form FDA 2877 Declaration for Imported Electronic Products Subject to Radiation Control Standards Reporting for Electronic Products	Form and Instruction
Form FDA 3633 General Variance Application Reporting for Electronic Products	Form and Instruction
Form FDA 3633 General Variance Application Reporting for Electronic Products	Form and Instruction
Form FDA 3635 LLS Notification Reporting for Electronic Products	Form and Instruction
Form FDA 3635 LLS Notification Reporting for Electronic Products	Form and Instruction
Form FDA 3637 Laser OEM Component Report Reporting for Electronic Products	Form and Instruction
Form FDA 3637 Laser OEM Component Report Reporting for Electronic Products	Form and Instruction
Form FDA 2579 REPORT OF ASSEMBLY OF A DIAGNOSTIC X-RAY SYSTEM Reporting for Electronic Products	Form
Form FDA 2579 REPORT OF ASSEMBLY OF A DIAGNOSTIC X-RAY SYSTEM Reporting for Electronic Products	Form
Form 3646 Mercury Vapor Lamp Products Radiation Safety Report Reporting for Electronic Products	Form
Form 3646 Mercury Vapor Lamp Products Radiation Safety Report Reporting for Electronic Products	Form
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: Modified

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:

table that charts list of instruments
Document Type	Form No.	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	FDA 3626	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3627	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3639	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3632	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3640	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3630	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3644	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3659	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3660	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3801	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3629	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3661	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3662	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3663	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3628	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3634	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3638	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3641	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3643	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3636	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3631	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3647	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3645	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3649	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3642	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 2767	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 2877	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3633	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3635	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3637	Yes	Yes	Fillable Fileable
Form	FDA 2579	Yes	Yes	Fillable Fileable
Form	3646	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: 19,851

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 %

table that charts list of burden
	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	981,203	943,191	38,012
Annual IC Time Burden (Hours)	341,676	238,932	102,744
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
No associated records found

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

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