Request for Determination of Eligibility Criteria--613(b) of FDASIA

Information to Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements

OMB: 0910-0661

IC ID: 206353

Information Collection (IC) Details

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Request for Determination of Eligibility Criteria--613(b) of FDASIA
 
No New
 
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 HDE Guidance.pdf http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm110203.pdf Yes No Printable Only

Health Consumer Health and Safety

 

2 0
   
Private Sector Businesses or other for-profits
 
   0 %

  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 2 0 2 0 0 0
Annual IC Time Burden (Hours) 20 0 20 0 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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