Information Collection

(Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements

IC 5678 under ICR 201904-0910-002 · OMB 0910-0025.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0025 can be found here:

Documents and Forms

Document Name Document Type
Form FDA 3662 (Burden Change Due to Rulemaking) 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 FDA.2579.Modified.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

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	(Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 1020.30 21 CFR 1030.10 21 CFR 1040.10 21 CFR 1002.10 21 CFR 1002.11 21 CFR 1002.12 21 CFR 1002.20 21 CFR 1002.50 21 CFR 1002.51 21 CFR 1002.13 21 CFR 1005.10 21 CFR 1005.25 21 CFR 1010.2 21 CFR 1010.4 21 CFR 1010.5 21 CFR 1010.13 21 CFR 1002.13

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	FDA 3662	Cephalometric Report (esubmitter)	3662 Abbrev Cephalometric report.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3663	Microwave products (non-oven) (esubmitter)	3663 Abbrev Microwave report.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3628	General Med X-ray annual report (esubmitter)	3628 General Annual Report (includes medical, analytical, industrial x-ray products) .pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3626	Diagnostic X-Ray	3626 DX Product Report form.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3626	Diagnostic X-Ray (esubmitter)	3626 DX Product Report.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3627	CT X-Ray	3627 CT Product Report form.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3627	CT X-Ray (esubmitter)	3627 CT Product Report.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3639	Cabinet X-Ray (esubmitter)	3639 Cabinet X-Ray Product Report.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3632	Laser	3632 Laser Product Report form.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3632	Laser (esubmitter)	3632 Laser Product Report.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3640	Laser Light Show	3640 LLS Report form.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3640	Laser Light Show (esubmitter)	3640 LLS Report.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3630	Sunlamp	3630 Sunlamp Product Report form.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3630	Sunlamp (esubmitter)	3630 Sunlamp Product Report.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3646	Mercury vapor lamp (esubmitter)	3646 Mercury Vapor Lamp Product Report.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3644	Ultrasonic therapy (esubmitter)	3644 Therapy Ultrasound Product Report.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3659	TV (esubmitter)	3659 TV Product Report.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3660	Microwave oven (esubmitter)	3660 MWO Product Report.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3801	UV lamps	3801 Medical UV Lamp Report form.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3629	General abbreviated report (esubmitter)	3629 General Abbreviated Report.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3661	X-Ray Report (esubmitter)	3661 Abbrev X-Ray report.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3639	Cabinet X-Ray Product Report	3639 Cabinet X-Ray Product Report form.pdf	Yes	Yes	Fillable Printable
Form and Instruction	FDA 3644	Therapy Ultrasound Product Report	3644 Therapy Ultrasound Product Report form.pdf	Yes	Yes	Fillable Printable
Form and Instruction	FDA 3660	Microwave oven	3660 MWO Product Report form.pdf	Yes	Yes	Fillable Printable
Form and Instruction	FDA 3661	X-Ray Report	3661 Abbrev X-Ray report form.pdf	Yes	Yes	Fillable Printable
Form and Instruction	FDA 3662	Cephalometric Report	3662 Abbrev Cephalometric report form.pdf	Yes	Yes	Fillable Printable
Form and Instruction	FDA 3663	Microwave products (non-oven)	3663 Abbrev Microwave report form.pdf	Yes	Yes	Fillable Printable
Form and Instruction	FDA 3634	TV annual report (esubmitter)	3634 TV Annual Report.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3638	Diagnostic X-ray annual report (esubmitter)	3638 DX Annual Report.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3641	Cabinet x-ray annual report (esubmitter)	3641 Cabinet X-Ray Annual Report.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3643	MIcrowave oven annual report	3643 MWO Annual Report.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3636	Laser annual report (esubmitter)	3636 Laser Annual Report.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3631	Sunlamp annual report (esubmitter)	3631 Sunlamp Annual Report.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 2579	Report of Assembly of a Diagnostic X-Ray System	FDA.2579.Modified.pdf	Yes	Yes	Fillable Fileable Signable
Form and Instruction	FDA 2767	Notice of Availability of Sample Electronic Product	2767 Sample Availability form.pdf	Yes	Yes	Fillable Fileable Signable
Form and Instruction	FDA 2877	Declaration for Imported Electronic Products Subject to Radiation Control Standards	2877 EPRC Imports form.pdf	Yes	Yes	Fillable Fileable Signable
Form and Instruction	FDA 3649	Accidental Radiation Occurrence Report	3649 ARO Report form .pdf	Yes	Yes	Fillable Fileable Signable
Form and Instruction	FDA 3649	Accidental Radiation Occurrence Report (esubmitter)	3649 ARO Report.pdf	Yes	Yes	Fillable Fileable Signable
Form and Instruction	FDA 3633	General Variance Request (esubmitter)	3633 General Variance Application.pdf	Yes	Yes	Fillable Fileable Signable
Form and Instruction	FDA 3635	Laser Show Notification (esubmitter)	3635 LLS Notification.pdf	Yes	Yes	Fillable Fileable Signable
Form and Instruction	FDA 3637	Original Equipment Manufacturer (OEM) Report (esubmitter)	3637 Laser OEM Component Report.pdf	Yes	Yes	Fillable Fileable Signable
Form and Instruction	FDA 3147	Application for a Variance from 21 CFR 1040.11(c) for a Laser Light Show, Display, or Device	3147 Application for LLS Variance form.pdf	Yes	Yes	Fillable Printable
Form and Instruction	FDA 3147	Application for a Variance from 21 CFR 1040.11(c) for a Laser Light Show, Display, or Device (esubmitter)	3147 Application for LLS Variance.pdf	Yes	Yes	Fillable Fileable Signable
Form and Instruction	FDA 3642	General Correspondence	3642 General Correspondence.pdf	Yes	Yes	Fillable Printable
Form and Instruction	FDA 3645	Therapy Ultrasound Annual Report	3645 Therapy Ultrasound Annual Report form.pdf	Yes	Yes	Fillable Printable
Form and Instruction	FDA 3645	Therapy Ultrasound Annual Report (esubmitter)	3645 Therapy Ultrasound Annual Report.pdf	Yes	Yes	Fillable Fileable Signable
Form and Instruction	FDA 3646	Mercury Vapor Lamp Product Report	3646 Mercury Vapor Lamp Product Report form.pdf	Yes	Yes	Fillable Fileable Signable
Form and Instruction	FDA 3647	Mercury Vapor Lamp Annual Report	3647 Mercury Vapor Lamp Annual Report form.pdf	Yes	Yes	Fillable Printable
Form and Instruction	FDA 3647	Mercury Vapor Lamp Annual Report (esubmitter)	3647 Mercury Vapor Lamp Annual Report.pdf	Yes	Yes	Fillable Fileable Signable
Form and Instruction	FDA 3636	Laser Annual Report	3636 Laser Annual Report form.pdf	Yes	Yes	Fillable Printable

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: 0

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

Percentage of Respondents Reporting Electronically: 0 %

	Requested	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	24	-18,009	18,033
Annual IC Time Burden (Hours)	102,744	-31,622	134,366
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

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