Information Collection

Reporting for Electronic Products: General Requirements

IC 5678 under ICR 201706-0910-005 · 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⚠️ Notice: This information collection may be referencing outdated material.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

Documents and forms in this information collection
Document Name	Document Type
Form FDA 3626 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
FDAS 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 (esubmitter) 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 tables, etc (esubmitter) 3661 Abbrev X-Ray report.pdf	Form and Instruction
FDA 3662 Cephalometric device (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

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 1030.10 21 CFR 1040.10 21 CFR 1005.25 21 CFR 1010.2 21 CFR 1010.4 21 CFR 1010.5 21 CFR 1010.13 21 CFR 1020.30

Information Collection Instruments:

table that charts list of 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 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	FDAS 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 (esubmitter)	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 tables, etc (esubmitter)	3661 Abbrev X-Ray report.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3662	Cephalometric device (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 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

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: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 0 %

table that charts list of burden
	Approved	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	18,033	18,033
Annual IC Time Burden (Hours)	134,366	134,366
Annual IC Cost Burden (Dollars)	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.