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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Leachables Study

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Application Number P890055 S026/ PAS002
Current Plan Approved 03/15/2011
Study Name OSB Lead-Leachables Study
General Study Protocol Parameters
Study Design Bench/Lab Study
Data Source Other Data Source
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The non-clinical study includes extraction and leachables testing. There are no stated hypotheses.
Study Population Description Not applicable. This is a bench/lab study.
Sample Size Not applicable. This is a bench/lab study.
Data Collection In order to determine the endpoints extraction testing and leachable testing will be performed.
Follow-up Visits and Length of Follow-up Not applicable. This is a bench/lab study.

OSB Lead-Leachables Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 06/17/2011 07/15/2011 On Time
one year report 12/17/2011 12/15/2011 On Time
18 month report 06/16/2012 06/15/2012 On Time
two year report 12/16/2012 12/17/2012 Overdue/Received
three year report 12/16/2013 12/16/2013 On Time
four year report 12/16/2014 12/11/2014 On Time
five year report 12/16/2015 12/15/2015 On Time
six year report 12/15/2016    
seven year report 12/15/2017    
eight year report 12/15/2018    
102 month report/final report 06/15/2019    

Contact Us

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

Phone: (301) 796-6134
Fax: (301) 847-8140

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