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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 P090018
Current Protocol Accepted 08/16/2010
Study Name OSB Lead-Extended Follow-up of PMA study
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 No Control
Analysis Type Analytical
Study Population Transit. Adolescent A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Final Study Results
Actual Number of Patients Enrolled 51
Actual Number of Sites Enrolled 3
Patient Followup Rate 98% at 4 months, 98% at 10 months, 65% at 2 years, 73% at 3 years, 86% at 4 years, 100% at 5 years
Final Safety Findings A total of three (3) SADEs in three (3) subjects have been reported during the   show the rest ...
Final Effectiveness Findings Overall mean Speech Reception Threshold (SRT) scores show significant improvement with Esteem compared with pre-implant   show the rest ...
Study Strengths and Weaknesses This is a single arm study with no comparator; however, the subjects served as their   show the rest ...
Recommendations for Labeling Changes Yes. A labeling update is recommended regarding the lifetime of the battery, long term device

effectiveness   show the rest ...

OSB Lead-Extended Follow-up of PMA study Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report 09/15/2010 09/16/2010 Overdue/Received
one year report 03/17/2011 03/16/2011 On Time
18 month report 09/15/2011 09/15/2011 On Time
2 year report 03/16/2012 03/14/2012 On Time
3 year report 03/16/2013 03/29/2013 Overdue/Received
4 year report 03/16/2014 03/14/2014 On Time
Final Report 03/16/2015 03/17/2015 Overdue/Received
resp to R19 RDEF-final report 08/01/2015 07/31/2015 On Time

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