• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies

  • Print
  • Share
  • E-mail

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

Show All Studies
Suggest Enhancement / Report Issue | Export to ExcelExport to Excel
Application Number P060023
Current Protocol Accepted 05/12/2009
Study Name OSB Lead-Enhanced Surveillance
Study Status Progress Adequate
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 Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Sponsor collects the information for any adverse events and complaints, including those which are not   show the rest ...
Study Population Description Study population is as per device indication.This device is indicated in skeletally mature patients for   show the rest ...
Sample Size NA
Data Collection The primary outcome variable, overall success, is defined below. A patient will be considered an   show the rest ...
Followup Visits and Length of Followup This reporting occurs at six-month intervals for the first two years of approval and then   show the rest ...
Final Study Results
Actual Number of Patients Enrolled
Actual Number of Sites Enrolled N/A - enhanced surveillance study
Patient Followup Rate Not applicable enhanced surveillance study

The study duration was 5 years.

Final Safety Findings A cumulative total of 1950* implants have been sold in the U.S. since the PMA   show the rest ...
Final Effectiveness Findings N/A
Study Strengths and Weaknesses The study permitted monitoring of the AEs occurrence in the broader population of the device   show the rest ...
Recommendations for Labeling Changes Yes

Bryan Cervical Disc implantation associated with higher level of surrounding tissue dissection than other artificial   show the rest ...

OSB Lead-Enhanced Surveillance Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
6 month report 11/10/2009 11/17/2009 Overdue/Received
1 year report 05/12/2010 05/12/2010 On Time
18 month report 11/10/2010 11/17/2010 Overdue/Received
2 year report 06/12/2011 08/25/2011 Overdue/Received
3 year report 05/11/2012 04/27/2012 On Time
4 year report 05/11/2013 04/23/2013 On Time
5 year report 05/11/2014 04/17/2014 On Time

Show All Studies