Transfer of 510(k) Notification: Agency GFI Recommendations

Electronic Submission of Medical Device Registration and Listing

OMB: 0910-0625

IC ID: 247600

Information Collection (IC) Details

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Transfer of 510(k) Notification: Agency GFI Recommendations
 
No Removed
 
Voluntary
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Agency Guidance Draft GFI Transfer 510(k) Clearance Q&A DEC 2014.pdf https://www.fdanews.com/ext/resources/files/01-15/01-05-15-transfer.pdf?1520701317 Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

6,113 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 0 0 0 -6,113 0 6,113
Annual IC Time Burden (Hours) 0 0 0 -9,152 0 9,152
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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