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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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MWP-HPV-159


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General
Application Number P100020 / PAS001
Current Plan Approved 04/19/2011
Study Name MWP-HPV-159
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Final Study Results
Number of Patients 4,291
Number of Sites 61
Follow-up Rate Above 80%
Safety Findings No severe adverse events were reported
Effect Findings A negative HPV result predicted a lower 3-year risk of ¡ÝCIN3 than did a negative cytology result.

The low 3-year (cumulative incidence ratio) CIR for a negative HPV result also confirmed the safety of a

3-year interval for HPV primary screening. The follow-up study confirmed the continued high risk of

HPV16 or HPV18 infection, with the observation that 1 in 4 women who tested HPV 16+ at Baseline and

1 in 9 who tested HPV18+ at Baseline were diagnosed with ¡ÝCIN3 within 3 years.

The follow-up data for the NILM population ¡Ý30 years demostrated safety over 3 years

of a negative HPV test at Baseline in the context of adjunct testing. In addition, the data demonstrated a higher risk associated with HPV16+ or HPV18+ results (9.56%).

Strengths & Weaknesses Strengths: Large sample size, high compliance at all follow up years, compliance with exit colposcopy

was 88%.

Weaknesses: Comparisons of cumulative Incidence rate (CIRs) of high-grade cervical disease between subjects with a positive and those with a negative Cobas HPV tests is only limited to up to 3 years.
Label Changes Labeling incorporating the long term Post approval study were submitted and approved


MWP-HPV-159 Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 10/18/2011 11/02/2011 Overdue/Received
1 year report 04/18/2012 04/24/2012 Overdue/Received
18 month report 10/17/2012 10/16/2012 On Time
2 year report 04/18/2013 04/03/2013 On Time
3 year report 04/18/2014 05/22/2014 Overdue/Received
Final Report 07/14/2014 07/14/2014 On Time


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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