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Agenda
Reg Review
ICR
View Information Collection (IC)
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 1005.25
21 CFR 1010.2
21 CFR 1010.4
21 CFR 1005.10
21 CFR 1010.5
21 CFR 1010.13
21 CFR 1020.30
21 CFR 1002.11
21 CFR 1002.13
21 CFR 1002.10
21 CFR 1002.20
21 CFR 1002.50
21 CFR 1002.51
21 CFR 1030.10
21 CFR 1040.10
21 CFR 1002.12
Information Collection Instruments:
Document Type
Form No.
Form Name
Instrument File
URL
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 3646
Mercury Vapor Lamp Products Radiation Safety Report
3646 Mercury Vapor Lamp 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 2579
Report of Assembly of a Diagnostic X-Ray System
2579 Assembler Report.pdf
Yes
Yes
Fillable Fileable
Form and Instruction
FDA 3637
Laser OEM Component Report
3637 Laser OEM Component Report.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:
18,033
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
Program Change Due to New Statute
Program Change Due to Agency Discretion
Change Due to Adjustment in Agency Estimate
Change Due to Potential Violation of the PRA
Previously Approved
Annual Number of Responses for this IC
18,033
0
0
0
0
18,033
Annual IC Time Burden (Hours)
134,366
0
0
0
0
134,366
Annual IC Cost Burden (Dollars)
0
0
0
0
0
0
Documents for IC
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.