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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 P100042
Current Protocol Accepted 10/28/2011
Study Name APTIMA HPV 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 Adult: >21
Final Study Results
Actual Number of Patients Enrolled 10,545
Actual Number of Sites Enrolled 13
Patient Followup Rate 96.76%
Final Safety Findings No issues concerning the safety of the APTIMA HPV Assay on either TIGRIS or PANTHER   show the rest ...
Final Effectiveness Findings The absolute risk of cervical disease is greater in subjects with positive APTIMA HPV Assay   show the rest ...
Study Strengths and Weaknesses This study was able to demonstrate that the APTIMA HPV assay¿s postmarket performance is characterized   show the rest ...
Recommendations for Labeling Changes Yes

APTIMA HPV Assay Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report 04/27/2012 04/26/2012 On Time
one year report 10/27/2012 10/16/2012 On Time
18 month report 04/27/2013 04/11/2013 On Time
two year report 10/27/2013 10/10/2013 On Time
three year report-FINAL REPORT 10/27/2014 05/01/2014 On Time

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