Medical Device User Fee Cover Sheet (Form FDA 3601)

Medical Device User Fee Cover Sheet and Device Facility User Fee Cover Sheet — Form FDA 3601 and Form 3601(a)

OMB: 0910-0511

IC ID: 6227

Information Collection (IC) Details

View Information Collection (IC)

Medical Device User Fee Cover Sheet (Form FDA 3601)
 
No Modified
 
Mandatory
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form FDA 3601 Medical Device User Fee Cover Sheet 0511_Form 3601.pdf Yes Yes Fillable Fileable Signable

Health Consumer Health and Safety

 

6,182 0
   
Private Sector Businesses or other for-profits
 
   100 %

  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 6,182 0 0 -197 0 6,379
Annual IC Time Burden (Hours) 1,855 0 0 -59 0 1,914
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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