First Year (one time)

Guidance Medical Device ISO 13485: 2003 Voluntary Audit Report Submission Pilot Program

OMB: 0910-0700

IC ID: 198426

Documents and Forms
Document Name
Document Type
Other-Screenshots
Information Collection (IC) Details

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First Year (one time)
 
No Modified
 
Voluntary
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Screenshots ISO13485 eSubmitter Screenshots.doc Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

567 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 567 0 34 0 0 533
Annual IC Time Burden (Hours) 23,814 0 1,428 0 0 22,386
Annual IC Cost Burden (Dollars) 17,010 0 1,020 0 0 15,990

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