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⚠️ Notice: This information collection may be referencing outdated material.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

Documents and forms in this information collection
Document Name	Document Type
Form FDA 3626 Diagnostic X-Ray (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 3626 Diagnostic X-Ray (esubmitter) (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 3627 CT X-Ray (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 3627 CT X-Ray (esubmitter) (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 3639 Cabinet X-Ray (esubmitter) (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 3632 Laser (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 3632 Laser (esubmitter) (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 3640 Laser Light Show (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 3640 Laser Light Show (esubmitter) (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 3630 Sunlamp (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 3630 Sunlamp (esubmitter) (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 3646 Mercury vapor lamp (esubmitter) (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 3644 Ultrasonic therapy (esubmitter) (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 3659 TV (esubmitter) (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 3660 Microwave oven (esubmitter) (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 3801 UV lamps (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 3629 General abbreviated report (esubmitter) (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 3661 X-Ray Report (esubmitter) (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 3662 Cephalometric Report (esubmitter) (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 3663 Microwave products (non-oven) (esubmitter) (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 3628 General Med X-ray annual report (esubmitter) (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 3634 TV annual report (esubmitter) (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 3638 Diagnostic X-ray annual report (esubmitter) (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 3641 Cabinet x-ray annual report (esubmitter) (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 3643 MIcrowave oven annual report (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 3636 Laser annual report (esubmitter) (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 3631 Sunlamp annual report (esubmitter) (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 2579 Report of Assembly of a Diagnostic X-Ray System (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 2767 Notice of Availability of Sample Electronic Product (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 2877 Declaration for Imported Electronic Products Subject to Radiation Control Standards (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 3649 Accidental Radiation Occurrence Report (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 3649 Accidental Radiation Occurrence Report (esubmitter) (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 3633 General Variance Request (esubmitter) (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 3635 Laser Show Notification (esubmitter) (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 3637 Original Equipment Manufacturer (OEM) Report (esubmitter) (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 3147 Application for a Variance from 21 CFR 1040.11(c) for a Laser Light Show, Display, or Device (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 3147 Application for a Variance from 21 CFR 1040.11(c) for a Laser Light Show, Display, or Device (esubmitter) (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 3642 General Correspondence (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 3645 Therapy Ultrasound Annual Report (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 3645 Therapy Ultrasound Annual Report (esubmitter) (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 3646 Mercury Vapor Lamp Product Report (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 3647 Mercury Vapor Lamp Annual Report (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 3647 Mercury Vapor Lamp Annual Report (esubmitter) (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 3636 Laser Annual Report (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 3639 Cabinet X-Ray Product Report (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 3644 Therapy Ultrasound Product Report (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 3660 Microwave oven (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 3661 X-Ray Report (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 3662 Cephalometric Report (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements	Form and Instruction
Form FDA 3663 Microwave products (non-oven) (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:

table that charts list of instruments
Document Type	Form No.	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	FDA 3626	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3626	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3627	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3627	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3639	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3632	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3632	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3640	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3640	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3630	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3630	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3646	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3644	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3659	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3660	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3801	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3629	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3661	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3662	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3663	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3628	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3634	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3638	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3641	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3643	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3636	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3631	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 2579	Yes	Yes	Fillable Fileable Signable
Form and Instruction	FDA 2767	Yes	Yes	Fillable Fileable Signable
Form and Instruction	FDA 2877	Yes	Yes	Fillable Fileable Signable
Form and Instruction	FDA 3649	Yes	Yes	Fillable Fileable Signable
Form and Instruction	FDA 3649	Yes	Yes	Fillable Fileable Signable
Form and Instruction	FDA 3633	Yes	Yes	Fillable Fileable Signable
Form and Instruction	FDA 3635	Yes	Yes	Fillable Fileable Signable
Form and Instruction	FDA 3637	Yes	Yes	Fillable Fileable Signable
Form and Instruction	FDA 3147	Yes	Yes	Fillable Printable
Form and Instruction	FDA 3147	Yes	Yes	Fillable Fileable Signable
Form and Instruction	FDA 3642	Yes	Yes	Fillable Printable
Form and Instruction	FDA 3645	Yes	Yes	Fillable Printable
Form and Instruction	FDA 3645	Yes	Yes	Fillable Fileable Signable
Form and Instruction	FDA 3646	Yes	Yes	Fillable Fileable Signable
Form and Instruction	FDA 3647	Yes	Yes	Fillable Printable
Form and Instruction	FDA 3647	Yes	Yes	Fillable Fileable Signable
Form and Instruction	FDA 3636	Yes	Yes	Fillable Printable
Form and Instruction	FDA 3639	Yes	Yes	Fillable Printable
Form and Instruction	FDA 3644	Yes	Yes	Fillable Printable
Form and Instruction	FDA 3660	Yes	Yes	Fillable Printable
Form and Instruction	FDA 3661	Yes	Yes	Fillable Printable
Form and Instruction	FDA 3662	Yes	Yes	Fillable Printable
Form and Instruction	FDA 3663	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 %

table that charts list of burden
	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

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.

Something went wrong when downloading this file. If you have any questions, please send an email to [email protected].