IDE Recordkeeping

Investigational Device Exemptions

OMB: 0910-0078

IC ID: 205260

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

View Information Collection (IC)

IDE Recordkeeping
No Modified
21 CFR 812

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 Immunization Management


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 6,065 0 0 -2,608 0 8,673
Annual IC Time Burden (Hours) 12,006 0 0 2,800 0 9,206
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.

© 2024 | Privacy Policy