Adverse Event Reporting

Adverse Event Program for Medical Devices (Medical Product Safety Network (MedSun))

OMB: 0910-0471

IC ID: 37668

Information Collection (IC) Details

View Information Collection (IC)

Adverse Event Reporting
 
No Modified
 
Voluntary
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form and Instruction FDA 3670 MedSun Database Additional Questions MedSun Database Additional Questions (Compiled).JPG Yes Yes Fillable Fileable
Form and Instruction FDA 3670 MedSun Database Contact Screen MedSun Database Contact Screen.JPG Yes Yes Fillable Fileable
Form and Instruction FDA 3670 MedSun Database Device Screen MedSun Database Device Screen.JPG No   Fillable Fileable
Form and Instruction FDA 3670 MedSun Database Event Screen MedSun Database Event Screen.JPG Yes Yes Fillable Fileable
Form and Instruction FDA 3670 MedSun Database Patient Screen MedSun Database Patient Screen.JPG Yes Yes Fillable Fileable
Form and Instruction FDA 3670 MedSun Database Test Screen MedSun Database Test Screen.JPG Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

250 0
   
Private Sector Not-for-profit institutions, Businesses or other for-profits
 
   99 %

  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 3,750 0 0 0 0 3,750
Annual IC Time Burden (Hours) 2,813 0 0 0 0 2,813
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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