Reporting for Electronic Products: General Requirements

Reporting and Recordkeeping for Electronic Products - General Requirements

OMB: 0910-0025

IC ID: 5678

Documents and Forms
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Information Collection (IC) Details

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Reporting for Electronic Products: General Requirements
 
No Modified
 
Mandatory
 
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

Document Type Form No. Form Name Instrument File URL 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

Health Consumer Health and Safety

 

7,497 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 53,392 0 0 17,105 0 36,287
Annual IC Time Burden (Hours) 81,460 0 0 -6,885 0 88,345
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

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