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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 P060028
Current Protocol Accepted 06/14/2013
Study Name OSB Lead-Post-approval Cont Access Study (PACAS)
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 Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The Continued Access Study (CAS) was initiated to allow for continued physician experience with the   show the rest ...
Study Population Description Women with Mentor¿s MemoryShape Medium Height, Moderate Profile (CPG Style 321) Breast Implants as indicated   show the rest ...
Sample Size A total of approximately 350 subjects who were enrolled in Mentor¿s Continued Access Study and   show the rest ...
Data Collection During the 5-year follow-up period, safety of the implants will continue to be measured by   show the rest ...
Followup Visits and Length of Followup Subjects will be seen by the investigator in the investigator's office once a year until   show the rest ...
Final Study Results
Actual Number of Patients Enrolled 2,003
Actual Number of Sites Enrolled 62
Patient Followup Rate 62% at Year 5
Final Safety Findings For the primary augmentation cohort, the KM estimated 5쳌year cumulative incidence rates for the key   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 recommended at this time. The labeling has already contained 3쳌and 6쳌year data   show the rest ...

OSB Lead-Post-approval Cont Access Study (PACAS) Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
one year report-Final Report 10/30/2014 10/24/2014 On Time

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