Guidance on Informed Consent for in Vitro Diagnostic Studies Using Leftover Human Specimens that are not Individually Identifiable

Guidance on Informed Consent for in Vitro Diagnostic Studies Using Leftover Human Specimens that are not Individually Identifiable

OMB: 0910-0582

IC ID: 6305

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Guidance on Informed Consent for in Vitro Diagnostic Studies Using Leftover Human Specimens that are not Individually Identifiable
 
No Modified
 
Required to Obtain or Retain Benefits
 
21 CFR 812.2

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Guidance Guidance Informed Consent for IVD.pdf http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm078384.htm Yes Yes Printable Only

Health Consumer Health and Safety

 

700 0
   
Private Sector Businesses or other for-profits
 
   95 %

  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 700 0 0 0 0 700
Annual IC Time Burden (Hours) 2,800 0 0 0 0 2,800
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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