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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 P060018
Current Protocol Accepted 07/16/2007
Study Name OSB Lead-Enhanced Surveillance
Study Status Completed
General Study Protocol Parameters
Study Design Enhanced Surveillance
Study involve follow-up of premarket cohort (Y/N) No
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is an enhanced surveillance system to collect the patietns demographic, clinical and device information   show the rest ...
Study Population Description Study includes all patients who received Prestige Cervical Disc after device approval as per device   show the rest ...
Sample Size N/A
Data Collection Complaints and Adverse events
Followup Visits and Length of Followup up to 5-year after device approval
Final Study Results
Actual Number of Patients Enrolled n/a
Actual Number of Sites Enrolled n/a
Patient Followup Rate n/a
Final Safety Findings Since the PMA approval date of July 16, 2007 through May 13, 2012, a cumulative   show the rest ...
Final Effectiveness Findings n/a
Study Strengths and Weaknesses

The study duration was for 5 years after PMA approval, allowing time to monitor adverse   show the rest ...
Recommendations for Labeling Changes

A labeling change based on the results from this study is not recommended because the   show the rest ...

OSB Lead-Enhanced Surveillance Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
6 month report (Enhanced Surveillance Study) 01/14/2008 01/14/2008 On Time
1 Year report (Enhanced Surveillance Study) 07/31/2008 07/15/2008 On Time
18 month report (Enhanced Surveillance Study) 01/13/2009 01/12/2009 On Time
2 year report (Enhanced Surveillance Study) 07/15/2009 07/21/2009 Overdue/Received
3 year report (Enhanced Surveillance Study) 07/15/2010 07/20/2010 Overdue/Received
4 year report (Enhanced Surveillanced Study) 07/15/2011 07/18/2011 Overdue/Received
5 year report (Final)(Enhanced Surveillance Study) 07/14/2012 07/13/2012 On Time

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