Identification of initial importers by foreign establishments

Electronic Submission of Medical Device Registration and Listing

OMB: 0910-0625

IC ID: 203606

Information Collection (IC) Details

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Identification of initial importers by foreign establishments
 
No Unchanged
 
Mandatory
 
21 CFR 807.41

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form FDA 3673 FDA 3673 Form FDA 3673 Screen shots.doc Yes Yes Fillable Fileable Signable

Health Consumer Health and Safety

 

12,983 0
   
Private Sector Businesses or other for-profits
 
   99 %

  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 12,983 0 0 0 0 12,983
Annual IC Time Burden (Hours) 6,492 0 0 0 0 6,492
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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