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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.

Links

Contact Information

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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General
Application Number P080015
Most Recent Protocol Version Approved 03/12/2009
Study Name Cervista HPV HR Assay
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 Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The study is a prospective, cohort study. The study consists of women that are 30   show the rest ...
Study Population Description Study Population: Women 30 years or older who have a NILM cytology result at baseline.   show the rest ...
Sample Size 2000 patients, 26 sites
Data Collection Safety endpoints do not apply. The effectiveness endpoints include cervical cytology, colposcopy/biopsy, and HPV 16/18   show the rest ...
Followup Visits and Length of Followup The study required 3 years of follow-up. Follow-up inculdes annual visits.
Final Study Results
Actual Number of Patients Enrolled 2026
Actual Number of Sites Enrolled 26
Patient Followup Rate 3 years
Final Safety Findings The estimates for Cervista HPV 16/18 positive over Cervista 16/18 negative relative cumulative risk at   show the rest ...
Final Effectiveness Findings Please see safety findings.
Study Strengths and Weaknesses The cumulative 3 year incidence for Cervista HPV 16/18 test is based on one HPV   show the rest ...
Recommendations for Labeling Changes The study results for the three year follow-up of women with NILM ¡Ý30 with normal   show the rest ...


Cervista HPV HR Assay Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
6 month report 09/13/2009 09/14/2009 Overdue/Received
1 year report 03/12/2010 03/11/2010 On Time
18 month report 09/10/2010 09/08/2010 On Time
2 year report 03/12/2011 03/08/2011 On Time
3 year report - final report 03/11/2012 07/27/2011 On Time
response to R7 RDEF - FINAL REPORT 10/22/2012 10/19/2012 On Time

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