IDE Reporting (including reports for nonsignificant studies)

Investigational Device Exemptions

OMB: 0910-0078

IC ID: 5718

Documents and Forms
Document Name
Document Type
Other-Agency Guidance
Information Collection (IC) Details

View Information Collection (IC)

IDE Reporting (including reports for nonsignificant studies)
 
No Modified
 
Mandatory
 
21 CFR 812 21 CFR 812.150

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Agency Guidance GFI Consent IVD human specimens April 2006.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

1,200 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 5,513 0 0 -2,461 0 7,974
Annual IC Time Burden (Hours) 53,897 0 0 6 0 53,891
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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.

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