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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.

Links

Contact Information

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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General
Application Number P040046
Current Protocol Accepted 02/20/2013
Study Name Core 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 B (as adults) : 18-21 yrs, Adult: >21
Final Study Results
Actual Number of Patients Enrolled 941 patients including 492 primary augmentation, 156 revision- augmentation, 225 primary reconstruction and 68 revision-reconstruction.   show the rest ...
Actual Number of Sites Enrolled 47
Patient Followup Rate The follow-up rate at 10 year was highest in the reconstruction group and lowest in   show the rest ...
Final Safety Findings The most commonly reported complications vary by the indication group. The most commonly reported complications   show the rest ...
Final Effectiveness Findings The majority of the patients and physicians were satisfied with the surgical outcome at 10   show the rest ...
Study Strengths and Weaknesses One of the study strengths is that the study was a prospective, multicenter study that   show the rest ...
Recommendations for Labeling Changes Yes. The labeling will be updated based on the safety and effectiveness results reported in   show the rest ...


Core Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
final report 05/20/2013 05/15/2013 On Time

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