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U.S. Department of Health and Human Services

Post-Approval Studies

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Post-Approval Studies

  • In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
  • The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
  • CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
  • In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.


Contact Information

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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Application Number P100020
Current Protocol Accepted 04/19/2011
Study Name MWP-HPV-159
Study Status Completed
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) Yes
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Final Study Results
Actual Number of Patients Enrolled 4,291
Actual Number of Sites Enrolled 61
Patient Followup Rate Above 80%
Final Safety Findings No severe adverse events were reported
Final Effectiveness Findings A negative HPV result predicted a lower 3-year risk of ¡ÝCIN3 than did a negative   show the rest ...
Study Strengths and Weaknesses Strengths: Large sample size, high compliance at all follow up years, compliance with exit colposcopy

was   show the rest ...
Recommendations for Labeling Changes Labeling incorporating the long term Post approval study were submitted and approved

MWP-HPV-159 Schedule

Report Schedule
Date Due
FDA Receipt
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

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