Reporting and Recordkeeping

Human Subject Protection; Acceptance of Data from Clinical Studies for Medical Devices

OMB: 0910-0741

IC ID: 206693

Documents and Forms
Document Name
Document Type
no available documents/forms check other ICs listed under this ICR
Information Collection (IC) Details

View Information Collection (IC)

Reporting and Recordkeeping
No Modified
21 CFR 807.87(j) 21 CFR 812.27(b)(4) 21 CFR 812.28(c) 21 CFR 812.28(b) 21 CFR 814.20 21 CFR 814.104 21 CFR 812.28(d) 21 CFR 812.140 21 CFR 812.28(a)(1)

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability

Health Consumer Health and Safety


2,010 0
Private Sector Businesses or other for-profits
   50 %

  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 2,010 0 0 2,010 0 0
Annual IC Time Burden (Hours) 17,780 0 0 17,780 0 0
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.

© 2023 | Privacy Policy