OMB.report

Federal forms, ICRs, and supporting documents

Information Collection

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

IC 6222 under ICR 202605-0910-003 · OMB 0910-0508.

Documents and Forms
Document Name
Document Type
Form
Form
Other-Guidance: Medical Device User
Other-Guidance: Medical Device User
Instruction
Instruction
Other-Screenshots
Other-Screenshots
Form
Form
Information Collection (IC) Details

View Information Collection (IC)

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
Other-Guidance: Medical Device User Fee Small Business Qualification and Certification Small-Business-Qualification-Certification-Guidance.pdf Yes No Printable Only
Instruction SBD online instructions page updated 12.19.24.pdf Yes Yes Printable Only
Other-Screenshots SBD CCP Screenshots.pdf Yes Yes Printable Only
Form FDA 3602N MDUFA Small Business Determination Request 0910-0508_June 2026 Current 3602N.pdf Yes Yes Fillable Printable

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 0 0 4,500
Annual IC Time Burden (Hours) 4,500 0 0 0 0 4,500
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.
Something went wrong when downloading this file. If you have any questions, please send an email to [email protected].