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

OMB: 0910-0700

IC ID: 198427

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

View Information Collection (IC)

No Modified

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


1,700 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 1,700 0 100 0 0 1,600
Annual IC Time Burden (Hours) 5,100 0 300 0 0 4,800
Annual IC Cost Burden (Dollars) 51,000 0 3,000 0 0 48,000

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.

© 2024 | Privacy Policy