Information Collection

Reporting for Electronic Products - General Requirements

IC 5678 under ICR 201005-0910-011 · 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⚠️ Notice: This information collection may be referencing outdated material.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 2767 Reporting for Electronic Products - General Requirements	Form
2767 Sample Electronic Product FDA_Form 2767 Sample Electronic Product.pdf	Form
2579 Report of Assembly of a Diagnostic XRay System FDA Form 2579_Report of Assembly of a Diagnostic XRay System.pdf	Form
3147 Laser Light Show Variance Request Form FDA_Form 3147 Laser Light Show Variance Request Form.pdf	Form
2877 Importation of Electronic Product FDA_Form 2877_Importation of Electronic Product.pdf	Form
3626 Diagnostic X-Ray Systems and Components Product Report FDA_Form 3626 Diagnostic X-Ray Systems and Components Product Report.pdf	Form
3627 Diagnostic X-Ray CT Products Product Report FDA_Form 3627 Diagnostic X-Ray CT Products Product Report.pdf	Form
3628 General Annual Report FDA_Form 3628 General Annual Report.pdf	Form
3629 Abbreviated Report FDA_Form 3629 Abbreviated Report.pdf	Form
3630 Sunlamp Product Report FDA_Form 3630 Sunlamp Product Report.pdf	Form
3631 Sunlamp Products Annual Report FDA_Form 3631 Sunlamp Products Annual Report.pdf	Form
3632 Lasers and Products Containing Lasers Product Report FDA_Form 3632 Lasers and Products Containing Lasers Product Report.pdf	Form
3633 General Variance Request FDA_Form 3633 General Variance Request.pdf	Form
3637 Laser Original Equipment Manufacturer Product Report FDA_Form 3637 Laser Original Equipment Manufacturer Product Report.pdf	Form
3635 Laser Light Show Notification FDA_Form 3635 Laser Light Show Notification.pdf	Form
3636 Lasers and Laser Light Show Annual Reports FDA_Form 3636 Lasers and Laser Light Show Annual Reports.pdf	Form
3638 X-Ray Components and Systems Annual Report FDA_Form 3638 X-Ray Components and Systems Annual Report.pdf	Form
3640 Laser Light Show Product Report FDA_Form 3640 Laser Light Show Product Report.pdf	Form
3634 Television Products Annual Report. FDA_Form 3634 Television Products Annual Report.pdf	Form
3639 Cabinet X-Ray Products Product Report FDA_Form 3639 Cabinet X-Ray Products Product Report.pdf	Form
3641 Cabinet X-Ray Products Annual Report FDA_Form 3641 Cabinet X-Ray Products Annual Report.pdf	Form
3642 General Correspondence FDA_Form 3642 General Correspondence.pdf	Form
3643 Microwave Oven Products Annual Report FDA_Form 3643 Microwave Oven Products Annual Report.pdf	Form
3644 Ultrasound Therapy Products Product Report FDA_Form 3644 Ultrasound Therapy Products Product Report.pdf	Form
3645 Ultrasound Therapy Products Annual Report FDA_Form 3645 Ultrasound Therapy Products Annual Report.pdf	Form
3646 Mercury Vapor Lamp Product Report FDA_Form 3646 Mercury Vapor Lamp Product Report.pdf	Form
3647 Mercury Vapor Lamp Annual Report FDA_Form 3647 Mercury Vapor Lamp Annual Report.pdf	Form
3649 Accidental Radiation Occurrence FDA_Form 3649 Accidental Radiation Occurrence.pdf	Form
3659 Television Products Product Report FDA_Form 3659 Television Products Product Report.pdf	Form
3660 Microwave Oven Product Report FDA_Form 3660 Microwave Oven Product Report.pdf	Form
3661 Abbreviated Report for X-Ray Tables, etc. FDA_Form 3661 Abbreviated Report for X-Ray Tables, etc.pdf	Form
3662 Abbreviated Report for Cephalometric Devices FDA_Form 3662 Abbreviated Report for Cephalometric Devices.pdf	Form
3663 Abbreviated Report for Microwave Products FDA_Form 3663 Abbreviated Report for Microwave Products.pdf	Form
3801 Medical UV lamps Product report FDA_Form 3801 Medical UV lamps Product report.pdf	Form

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 1000.1004.2 21 CFR 1000.1002.3 21 CFR 1000.1002.10 21 CFR 1000.1002.11 21 CFR 1000.1002.12 21 CFR 1000.1002.13 21 CFR 1000.1002.31 21 CFR 1000.1002.40 21 CFR 1000.1002.20 21 CFR 1000.1002.30 21 CFR 1000.1002.41 21 CFR 1000.1002.50 21 CFR 1000.1002.51 21 CFR 1000.1003.10 21 CFR 1000.1003.11 21 CFR 1000.1003.20 21 CFR 1000.1003.21 21 CFR 1000.1003.22 21 CFR 1000.1003.30 21 CFR 1000.1003.31 21 CFR 1000.1005.21 21 CFR 1000.1005.22 21 CFR 1000.1005.25 21 CFR 1000.1005.10 21 CFR 1000.1010.2 21 CFR 1000.1010.3 21 CFR 1000.1010.4 21 CFR 1000.1010.5 21 CFR 1000.1010.13 21 CFR 1000.1020.20 21 CFR 1000.1020.30 21 CFR 1000.1020.32 21 CFR 1000.1020.33 21 CFR 1000.1020.40 21 CFR 1000.1030.10 21 CFR 1000.1040.10 21 CFR 1000.1040.11 21 CFR 1000.1040.30 21 CFR 1000.1050.10

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	2767	Sample Electronic Product	FDA_Form 2767 Sample Electronic Product.pdf	Yes	Yes	Fillable Printable
Form	2579	Report of Assembly of a Diagnostic XRay System	FDA Form 2579_Report of Assembly of a Diagnostic XRay System.pdf	Yes	Yes	Fillable Printable
Form	3147	Laser Light Show Variance Request Form	FDA_Form 3147 Laser Light Show Variance Request Form.pdf	Yes	Yes	Fillable Printable
Form	2877	Importation of Electronic Product	FDA_Form 2877_Importation of Electronic Product.pdf	Yes	Yes	Fillable Printable
Form	3626	Diagnostic X-Ray Systems and Components Product Report	FDA_Form 3626 Diagnostic X-Ray Systems and Components Product Report.pdf	Yes	Yes	Fillable Fileable
Form	3627	Diagnostic X-Ray CT Products Product Report	FDA_Form 3627 Diagnostic X-Ray CT Products Product Report.pdf	Yes	Yes	Fillable Printable
Form	3628	General Annual Report	FDA_Form 3628 General Annual Report.pdf	Yes	Yes	Fillable Printable
Form	3629	Abbreviated Report	FDA_Form 3629 Abbreviated Report.pdf	Yes	Yes	Fillable Printable
Form	3630	Sunlamp Product Report	FDA_Form 3630 Sunlamp Product Report.pdf	Yes	Yes	Fillable Printable
Form	3631	Sunlamp Products Annual Report	FDA_Form 3631 Sunlamp Products Annual Report.pdf	Yes	Yes	Fillable Printable
Form	3632	Lasers and Products Containing Lasers Product Report	FDA_Form 3632 Lasers and Products Containing Lasers Product Report.pdf	Yes	Yes	Fillable Printable
Form	3633	General Variance Request	FDA_Form 3633 General Variance Request.pdf	Yes	Yes	Fillable Printable
Form	3637	Laser Original Equipment Manufacturer Product Report	FDA_Form 3637 Laser Original Equipment Manufacturer Product Report.pdf	Yes	Yes	Fillable Printable
Form	3635	Laser Light Show Notification	FDA_Form 3635 Laser Light Show Notification.pdf	Yes	Yes	Fillable Printable
Form	3636	Lasers and Laser Light Show Annual Reports	FDA_Form 3636 Lasers and Laser Light Show Annual Reports.pdf	Yes	Yes	Fillable Printable
Form	3638	X-Ray Components and Systems Annual Report	FDA_Form 3638 X-Ray Components and Systems Annual Report.pdf	Yes	Yes	Fillable Printable
Form	3640	Laser Light Show Product Report	FDA_Form 3640 Laser Light Show Product Report.pdf	Yes	Yes	Fillable Printable
Form	3634	Television Products Annual Report.	FDA_Form 3634 Television Products Annual Report.pdf	Yes	Yes	Fillable Printable
Form	3639	Cabinet X-Ray Products Product Report	FDA_Form 3639 Cabinet X-Ray Products Product Report.pdf	Yes	Yes	Fillable Printable
Form	3641	Cabinet X-Ray Products Annual Report	FDA_Form 3641 Cabinet X-Ray Products Annual Report.pdf	Yes	Yes	Fillable Printable
Form	3642	General Correspondence	FDA_Form 3642 General Correspondence.pdf	Yes	Yes	Fillable Printable
Form	3643	Microwave Oven Products Annual Report	FDA_Form 3643 Microwave Oven Products Annual Report.pdf	Yes	Yes	Fillable Printable
Form	3644	Ultrasound Therapy Products Product Report	FDA_Form 3644 Ultrasound Therapy Products Product Report.pdf	Yes	Yes	Fillable Printable
Form	3645	Ultrasound Therapy Products Annual Report	FDA_Form 3645 Ultrasound Therapy Products Annual Report.pdf	Yes	Yes	Fillable Printable
Form	3646	Mercury Vapor Lamp Product Report	FDA_Form 3646 Mercury Vapor Lamp Product Report.pdf	Yes	Yes	Fillable Printable
Form	3647	Mercury Vapor Lamp Annual Report	FDA_Form 3647 Mercury Vapor Lamp Annual Report.pdf	Yes	Yes	Fillable Printable
Form	3649	Accidental Radiation Occurrence	FDA_Form 3649 Accidental Radiation Occurrence.pdf	Yes	Yes	Fillable Printable
Form	3659	Television Products Product Report	FDA_Form 3659 Television Products Product Report.pdf	Yes	Yes	Fillable Printable
Form	3660	Microwave Oven Product Report	FDA_Form 3660 Microwave Oven Product Report.pdf	Yes	Yes	Fillable Printable
Form	3661	Abbreviated Report for X-Ray Tables, etc.	FDA_Form 3661 Abbreviated Report for X-Ray Tables, etc.pdf	Yes	Yes	Fillable Printable
Form	3662	Abbreviated Report for Cephalometric Devices	FDA_Form 3662 Abbreviated Report for Cephalometric Devices.pdf	Yes	Yes	Fillable Printable
Form	3663	Abbreviated Report for Microwave Products	FDA_Form 3663 Abbreviated Report for Microwave Products.pdf	Yes	Yes	Fillable Printable
Form	3801	Medical UV lamps Product report	FDA_Form 3801 Medical UV lamps Product report.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: 4,100

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	Previously Approved
Annual Number of Responses for this IC	36,287	-11,068	47,355
Annual IC Time Burden (Hours)	88,345	-254,544	342,889
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.