Reporting and Recordkeeping for Electronic Products - General Requirements

Reporting and Recordkeeping for Electronic Products - General Requirements

OMB: 0910-0025

IC ID: 5678

Documents and Forms
Document Name
Document Type
Form and Instruction
Form and Instruction
Form and Instruction
Form and Instruction
Form and Instruction
Form and Instruction
Form and Instruction
Form and Instruction
Form and Instruction
Form and Instruction
Form and Instruction
Form and Instruction
Form and Instruction
Form and Instruction
Form and Instruction
Form and Instruction
Form and Instruction
Form and Instruction
Form and Instruction
Form and Instruction
Form and Instruction
Form and Instruction
Form and Instruction
Form and Instruction
Form and Instruction
Form and Instruction
Form and Instruction
Form and Instruction
Information Collection (IC) Details

View Information Collection (IC)

Reporting and Recordkeeping for Electronic Products - General Requirements
 
No Modified
 
Mandatory
 
21 CFR 1000.1004.2 21 CFR 1000.1005.10 21 CFR 1000.1005.21 21 CFR 1000.1005.22 21 CFR 1000.1005.25 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 21 CFR 1000.1002.3 21 CFR 1000.1002.11 21 CFR 1000.1002.10 21 CFR 1000.1002.12 21 CFR 1000.1002.13 21 CFR 1000.1002.20 21 CFR 1000.1002.30 21 CFR 1000.1002.31 21 CFR 1000.1002.40 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

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form and Instruction 3641 Cabinet XRay Annual Report 25_FDA_Form_3641_Cabinet_XRay_Annual_Report.pdf Yes Yes Fillable Printable
Form and Instruction 3649 Accidental Radiation Occurence 09_FDA_Form_3649_Accidental_Radiation_Occurrence.pdf Yes Yes Fillable Printable
Form and Instruction 3626 Diagnostic XRay Major Componets Product 10_FDA_Form_3626_Diagnostic_XRay_Major_Components_Product_Report.pdf Yes Yes Fillable Printable
Form and Instruction 3627 Diagnostic XRay CT Report 11_FDA_Form_3627_Diagnostic_XRay_CT_Report.pdf Yes Yes Fillable Printable
Form and Instruction 3628 General Annual Report 12_FDA_Form_3628_General_Annual_Report.pdf Yes Yes Fillable Printable
Form and Instruction 2767 Notice of Availability-Sample electronic Product 06_FDA_Form_2767_Notice_Availability_Sample_Electronic_Product.pdf Yes Yes Fillable Printable
Form and Instruction 3147 Laser Light Show Variance Application 08_FDA_Form_3147_Laser_Light_Show_Variance_Application.pdf Yes Yes Fillable Printable
Form and Instruction 3629 Abbreviated Report 13_FDA_Form_3629_Abbreviated_Report.pdf Yes Yes Fillable Printable
Form and Instruction 3630 Sunlamp Product Report 14_FDA_Form_3630_Sunlamp_Product_Report.pdf Yes Yes Fillable Printable
Form and Instruction 3631 Sunlamp Annual Report 15_FDA_Form_3631_Sunlamp_Annual_Report_.pdf Yes Yes Fillable Printable
Form and Instruction 3632 Laser Product Report 16_FDA_Form_3632_Laser_Product_Report.pdf Yes Yes Fillable Printable
Form and Instruction 3633 General Variance Request 17_FDA_Form_3633_General_Variance_Request.pdf.pdf Yes Yes Fillable Printable
Form and Instruction 3634 TV Annual Report 18_FDA_Form_3634_TV_Annual_Report.pdf Yes Yes Fillable Printable
Form and Instruction 3635 Laser Light Show Nodification 19_FDA_Form_3635_Laser_Light_Show_Notification.pdf Yes Yes Fillable Printable
Form and Instruction 3636 Laser Light Show Annual Report 20_FDA_Form_3636_Laser_Light_Show_Annual_Report.pdf Yes Yes Fillable Printable
Form and Instruction 3637 Laser Original equipment Manufacturer Report 21_FDA_Form_3637_Laser_Original_Equipment_Manufacturer_Report.pdf Yes Yes Fillable Printable
Form and Instruction 3638 Annual Report XRay Components and Systems 22_FDA_Form_3638_Annual_Report_XRay_Components_and_Systems.pdf Yes Yes Fillable Printable
Form and Instruction 3639 Cabinet XRay System Product Report 23_FDA_Form_3639_Cabinet_XRay_System_Product_Report.pdf Yes Yes Fillable Printable
Form and Instruction 3640 Laser Light Show Product Report 24_FDA_Form_3640_Laser_Light_Show_Product_Report.pdf Yes Yes Fillable Printable
Form and Instruction 3642 General Correspondence 26_FDA_Form_3642_General_Correspondence.pdf Yes Yes Fillable Printable
Form and Instruction 3643 Microwave Annual Report 27_FDA_Form_3643_Microwave_Annual_Report.pdf Yes Yes Fillable Printable
Form and Instruction 3644 Ultrasonic Therapy Product Report 28_FDA_Form_3644_Ultrasonic_Therapy_Product_Report.pdf Yes Yes Fillable Printable
Form and Instruction 3645 Ultrasonic Therapy Annual Report 29_FDA_Form_3645_Ultrasonic_Therapy_Annual_Report.pdf Yes Yes Fillable Printable
Form and Instruction 3646 Mercury Vapor Lamp Product Report 30_FDA_Form_3646_Mercury_Vapor_Lamp_Product_Report.pdf Yes Yes Fillable Printable
Form and Instruction 3647 Mercury Vapor Lamp Annual Report 31_FDA_Form_3647_Mercury_Vapor_Lamp_Annual_Report.pdf Yes Yes Fillable Printable
Form and Instruction 2877 Declaration of Imported Electronic Products 07_FDA_Form_2877_Declaration_Imported_Electronic_Products.pdf Yes Yes Fillable Printable
Form and Instruction 2579 Assembler Report 05_FDA_2579_Assembler_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 47,355 0 0 12 0 47,343
Annual IC Time Burden (Hours) 342,889 0 0 17,932 0 324,957
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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.

© 2024 OMB.report | Privacy Policy