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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 P950039 S026/ 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 of this study is to evaluate the performance of the TP-5000 processors in detection of ASC-H+ and HSIL+ disease in a clinical use setting compared to the detection of ASC-H+ and HSIL+ disease in the same clinical setting using the TP-2000 processors. This evaluation will be performed at multiple sites.

A secondary objective is to compare the prospective and retrospective percent biopsy confirmed rate for all ASC-H+ and HSIL+ diagnosis. This evaluation will be performed at least one site.

Study Population Description The study population is the entire routine screening population of the selected sites.
Sample Size Sample size will be determined by the selection of clinical laboratories included in the study and duration of the study.

There will be at least five (5) clinical laboratories participating in this study.

Data Collection Data from all cytologic results for all patients screened during the study specific time period, which will be converted into prevalence rates for study reporting.
Follow-up Visits and Length of Follow-up 24 months

Disease prevalence rates will be collected and reported on a quarterly basis.



OIR Lead-Post-Approval Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 05/27/2016 05/27/2016 On Time
one year report 11/30/2016 11/30/2016 On Time
18 month report 05/30/2017 05/30/2017 On Time
two year report 11/30/2017    
three year report 11/30/2018    
four year report 11/30/2019    
five year report 11/30/2020    


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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