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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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Externalization and Abrasion Sub-Study

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Study Status Progress Adequate
Application Number P950022 S085/ PAS002
Date Current Protocol Accepted 02/21/2014
Study Name Externalization and Abrasion Sub-Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs

Externalization and Abrasion Sub-Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
two year report 08/21/2016 08/18/2016 On Time
three year report 03/21/2017 03/22/2017 Overdue/Received
four year report 03/21/2018 03/20/2018 On Time
five year report 03/21/2019 03/20/2019 On Time
six year report 03/20/2020 03/19/2020 On Time
seven year report 03/21/2021    

Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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