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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 P080014
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 There are no safety endpoints, The effectiveness endpoints include cervical cytology, colposcopy/biopsy, and high risk   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 cumulative risk of ¡ÝCIN2 after 3 years among subjects who had a positive Cervista   show the rest ...
Final Effectiveness Findings Please see safety findings.
Study Strengths and Weaknesses Of the 2026 women enrolled in the PAS, only 6 had the study outcomes/CIN2+, namely   show the rest ...
Recommendations for Labeling Changes It is recommended that the label be updated to reflect the study results for the   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
additional information for final report 01/03/2013 01/03/2013 On Time
response to RDEF -final report 03/10/2013 03/07/2013 On Time

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