Medical Product Reporting Network (MedSun)

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

OMB: 0910-0471

IC ID: 37668

Documents and Forms
Information Collection (IC) Details

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Medical Product Reporting Network (MedSun)
No Modified

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form and Instruction FDA 3670 MedSun FDA e-Form 3670 MedSun.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety


300 0
Private Sector Businesses or other for-profits, Not-for-profit institutions
   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 5,400 0 0 1,650 0 3,750
Annual IC Time Burden (Hours) 2,700 0 0 -113 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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