MDUFMA Small Business Qualification Certification (Form FDA 3602 and Form FDA 3602A))

MDUFMA Small Business Qualification Certification

OMB: 0910-0508

IC ID: 6222

Information Collection (IC) Details

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MDUFMA Small Business Qualification Certification (Form FDA 3602 and Form FDA 3602A))
 
No Modified
 
Required to Obtain or Retain Benefits
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form Form FDA 3602 MDUFA Small Business Qualification and Certification (In the United States) FDA 3602.pdf No   Printable Only
Form Form FDA 3602A MDUFA Small Business Qualification and Certification (Outside of United States) FDA 3602a.pdf No   Printable Only
Other-Guidance Medical Device User Fee Small Business Qualification Guidance.pdf Yes No Printable Only

Health Consumer Health and Safety

 

4,500 0
   
Private Sector Businesses or other for-profits
 
   90 %

  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 4,500 0 0 -2,500 0 7,000
Annual IC Time Burden (Hours) 4,500 0 0 -2,500 0 7,000
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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