Reporting for Electronic Products - General Requirements

Reporting and Recordkeeping for Electronic Products - General Requirements

OMB: 0910-0025

IC ID: 5678

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Information Collection (IC) Details

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Reporting for Electronic Products - General Requirements
 
No Modified
 
Mandatory
 
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

Document Type Form No. Form Name Instrument File URL 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

Health Consumer Health and Safety

 

4,100 0
   
Private Sector Businesses or other for-profits
 
   0 %

  Approved Program Change Due to New Statute Program Change Due to Agency Discretion Change Due to Adjustment in Agency Estimate Change Due to Potential Violation of the PRA Previously Approved
Annual Number of Responses for this IC 36,287 0 0 -11,068 0 47,355
Annual IC Time Burden (Hours) 88,345 0 0 -254,544 0 342,889
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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