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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-Post-Approval Study


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General
Study Status Progress Adequate
Application Number P970018 S033/ PAS001
Study Name OIR Lead-Post-Approval Study
General Study Protocol Parameters
Study Design Prospective & Retrospective Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The primary objective is to evaluate the performance of the BD SurePath Collection Vial in detection of LSIL+ results in a clinical use setting. The PAS consists of two study arms to compare the performance of the BD SurePath Liquid-based Pap Test when using 1) the modified BD SurePath Collection Vial (modified vial), and 2) historical data with the previously approved SurePath vial (previous vial). In both study arms, collected cells will be enriched using the BD PrepMate, slides will be prepared using the BD PrepStain and then slides will be evaluated using the FocalPoint GS Imaging System (FPGS). The study population is the entire routine screening population; approximately 15,000 results will be collected per arm. Historical and prospective calculated Bethesda result rates will be stratified into following categories: a) NILM, b) ASCUS, c) ASC-H, d) LSIL and e) HSIL+; and reported for the entire cohort, as well as by laboratory (site). False negative fraction will be calculated by site utilizing each site's quality control (QC) results from NILMs and overall. False negatives are defined as QC results of ASCUS+, LSIL+ and HSIL+, with overall and by site, including 95% confidence interval. The similarity and difference in Bethesda category (abnormality) rates will be calculated (within the context of the unmatched Historical and Prospective populations). If the PAS results indicate clinically and statistically significant inferior performance attributable to use of the Modified Vial, then a limitation will be included in the device labeling and a field action will be conducted to inform users that all potentially impacted slides should undergo re-evaluation using full manual slide review.



Study Population Description The study population is the entire routine screening population of the selected sites.
Sample Size There will be at least two (2) clinical laboratories participating in this study. Approximately 15,000 data points will be collected per study arm.
Data Collection Based on the false negative rate for each cut-off (ASCUS+, LSIL+ and HSIL+), the ratios of 1 minus sensitivity and ratio of specificities for the modified vial vs. previous vial at each cut-off will be calculated.



Follow-up Visits and Length of Follow-up N/A


OIR Lead-Post-Approval Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 06/02/2017 06/02/2017 On Time
one year report 12/02/2017    
18 month report 06/02/2018    
two year report 12/02/2018    
three year report 12/02/2019    
four year report 12/01/2020    


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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