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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 P040046
Study Name OSB Lead-Continued Access Study (Natrelle 410 CAS)
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 B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a multicenter, prospective, nonrandomized study to evaluate the safety and effectiveness of NATRELLE®   show the rest ...
Study Population Description Subjects signed informed consent documents and underwent implantation and some follow-up as part of the   show the rest ...
Sample Size The sample size of approximately 3,500 subjects across approximately 110 sites is based on the   show the rest ...
Data Collection At all post-implantation visits, the Investigator will evaluate the occurrence of local complications that occurred   show the rest ...
Followup Visits and Length of Followup Subjects will continue to be evaluated at their remaining follow-up visits 1, 2, and 5   show the rest ...
Final Study Results
Actual Number of Patients Enrolled A total of 7274 subjects were enrolled who reached the 5-year follow-up window: 3267 Augmentation,

1390   show the rest ...
Actual Number of Sites Enrolled 52
Patient Followup Rate At year 5, the follow-up rates by cohort were: 62.3% Augmentation, 54.7% Revision-Augmentation,

48.3% Reconstruction, and   show the rest ...
Final Safety Findings Following are the observed Year 5 Kaplan-Meier rates with 95% confidence intervals for key complications   show the rest ...
Final Effectiveness Findings n/a
Study Strengths and Weaknesses The Continued Access Study (CAS) was initiated to allow for continued physician experience with the   show the rest ...
Recommendations for Labeling Changes No labeling change is recommended at this time. The labeling contains 3, 5, 7 and   show the rest ...

OSB Lead-Continued Access Study (Natrelle 410 CAS) Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
one year report 02/20/2014 02/20/2014 On Time
Final Report 02/20/2015 02/20/2015 On Time

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