Information Collection

Reporting for Electronic Products: General Requirements

IC 5678 under ICR 201311-0910-008 · 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⚠️ Notice: This information collection may be referencing outdated material.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 3626 Reporting for Electronic Products: General Requirements Form and Instruction
FDA 3626 Diagnostic X-Ray 3626 pdf D X-Ray BlankForm.pdf Form and Instruction
FDA 3626 Diagnostic X-Ray (esubmitter) 3626 esubmitter D X-Ray BlankForm.pdf Form and Instruction
FDA 3627 CT X-Ray 3627 pdf DX CT Blank form.pdf Form and Instruction
FDA 3627 CT X-Ray (esubmitter) 3627 esubmitter DX CT Blank form.pdf Form and Instruction
FDA 3639 Cabinet X-Ray (esubmitter) 3639 esubmitter Cab X-Ray blank form.pdf Form and Instruction
FDA 3632 Laser 3632 pdf Laser Blank form.pdf Form and Instruction
FDA 3632 Laser (esubmitter) 3632 esubmitter Laser Blank form.pdf Form and Instruction
FDA 3640 Laser Light Show 3640 pdf LLS Show Blank form.pdf Form and Instruction
FDA 3640 Laser Light Show (esubmitter) 3640 esubmitter LLS Show Blank form.pdf Form and Instruction
FDA 3630 Sunlamp 3630 pdf Sunlamp Blank form.pdf Form and Instruction
FDA 3630 Sunlamp (esubmitter) 3630 esubmitter Sunlamp Blank form.pdf Form and Instruction
FDAS 3646 Mercury vapor lamp (esubmitter) 3646 esubmitter Mercury Vapor Blank form.pdf Form and Instruction
FDA 3644 Ultrasonic therapy (esubmitter) 3644 esubmitter Therapy Ultrasound Blank.pdf Form and Instruction
FDA 3659 TV (esubmitter) 3659 esubmitter TV Blank form.pdf Form and Instruction
FDA 3660 Microwave oven (esubmitter) 3660 esubmitter MWO Blank form.pdf Form and Instruction
FDA 3801 UV lamps (esubmitter) 3801 esubmitter Medical UV Lamps Blank.pdf Form and Instruction
FDA 3629 General abbreviated report (esubmitter) 3629 esubmitter Abbreviated Blank Form.pdf Form and Instruction
FDA 3661 X-ray tables, etc (esubmitter) 3661 esubmitter Abbrev X-Ray Blank form.pdf Form and Instruction
FDA 3662 Cephalometric device (esubmitter) 3662 esubmitter Cephalometric Blank form.pdf Form and Instruction
FDA 3663 Microwave products (non-oven) (esubmitter) 3663 esubmitter Abbrev Microwave Blank.pdf Form and Instruction
FDA 3628 General Med X-ray annual report (esubmitter) 3628 esubmitter Med X-Ray Annual Blank Form.pdf Form and Instruction
FDA 3634 TV annual report (esubmitter) 3634 esubmitter TV Annual Blank Form.pdf Form and Instruction
FDA 3638 Diagnostic X-ray annual report (esubmitter) 3638 esubmitter X-Ray Annual.pdf Form and Instruction
FDA 3641 Cabinet x-ray annual report (esubmitter) 3641 esubmitter Cab X-Ray Blank Form.pdf Form and Instruction
FDA 3643 MIcrowave oven annual report 3643 esubmitter MWO Annual Blank Form.pdf Form and Instruction
FDA 3636 Laser annual report (esubmitter) 3636 esubmitter Laser Annual Blank Form.pdf Form and Instruction
FDA 3631 Sunlamp annual report (esubmitter) 3631 esubmitter Sunlamp Annual Blank Form.pdf Form and Instruction

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	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 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 1020.30 21 CFR 1030.10 21 CFR 1040.10

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	FDA 3626	Diagnostic X-Ray	3626 pdf D X-Ray BlankForm.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3626	Diagnostic X-Ray (esubmitter)	3626 esubmitter D X-Ray BlankForm.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3627	CT X-Ray	3627 pdf DX CT Blank form.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3627	CT X-Ray (esubmitter)	3627 esubmitter DX CT Blank form.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3639	Cabinet X-Ray (esubmitter)	3639 esubmitter Cab X-Ray blank form.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3632	Laser	3632 pdf Laser Blank form.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3632	Laser (esubmitter)	3632 esubmitter Laser Blank form.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3640	Laser Light Show	3640 pdf LLS Show Blank form.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3640	Laser Light Show (esubmitter)	3640 esubmitter LLS Show Blank form.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3630	Sunlamp	3630 pdf Sunlamp Blank form.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3630	Sunlamp (esubmitter)	3630 esubmitter Sunlamp Blank form.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDAS 3646	Mercury vapor lamp (esubmitter)	3646 esubmitter Mercury Vapor Blank form.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3644	Ultrasonic therapy (esubmitter)	3644 esubmitter Therapy Ultrasound Blank.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3659	TV (esubmitter)	3659 esubmitter TV Blank form.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3660	Microwave oven (esubmitter)	3660 esubmitter MWO Blank form.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3801	UV lamps (esubmitter)	3801 esubmitter Medical UV Lamps Blank.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3629	General abbreviated report (esubmitter)	3629 esubmitter Abbreviated Blank Form.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3661	X-ray tables, etc (esubmitter)	3661 esubmitter Abbrev X-Ray Blank form.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3662	Cephalometric device (esubmitter)	3662 esubmitter Cephalometric Blank form.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3663	Microwave products (non-oven) (esubmitter)	3663 esubmitter Abbrev Microwave Blank.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3628	General Med X-ray annual report (esubmitter)	3628 esubmitter Med X-Ray Annual Blank Form.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3634	TV annual report (esubmitter)	3634 esubmitter TV Annual Blank Form.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3638	Diagnostic X-ray annual report (esubmitter)	3638 esubmitter X-Ray Annual.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3641	Cabinet x-ray annual report (esubmitter)	3641 esubmitter Cab X-Ray Blank Form.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3643	MIcrowave oven annual report	3643 esubmitter MWO Annual Blank Form.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3636	Laser annual report (esubmitter)	3636 esubmitter Laser Annual Blank Form.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3631	Sunlamp annual report (esubmitter)	3631 esubmitter Sunlamp Annual Blank Form.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: 7,497	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	53,392	17,105	36,287
Annual IC Time Burden (Hours)	81,460	-6,885	88,345
Annual IC Cost Burden (Dollars)	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.