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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)
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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OIR Lead-FreeStyle Libre Flash Glucose Monitoring


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General
Study Status Protocol Pending
Application Number P160030 / PAS001
Study Name OIR Lead-FreeStyle Libre Flash Glucose Monitoring
General Study Protocol Parameters


OIR Lead-FreeStyle Libre Flash Glucose Monitoring Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 03/28/2018 03/26/2018 On Time
one year report 09/27/2018    
18 month report 03/28/2019    
two year report 09/27/2019    
three year report 09/26/2020    


Contact Us
Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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