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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 P000053 S005
Most Recent Protocol Version Approved 02/07/2007
Study Name Registry AMS MC-0611
Study Status Completed
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source Sponsor Registry
Comparison Group Concurrent & Historical Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The sponsor has created a registry-based study that will include all patients who have received   show the rest ...
Study Population Description Study population is as per device indication. This device is used to treat urinary incontinence   show the rest ...
Sample Size All comers registry
Data Collection Primary endpoint is device replacement surgery
Followup Visits and Length of Followup There are no follow up visits in this study; the entire study will include 5   show the rest ...
Final Study Results
Actual Number of Patients Enrolled 17,063 subjects
Actual Number of Sites Enrolled 2,240 sites
Patient Followup Rate

There was no formal follow쳌]up in this registry쳌]based study. The post쳌]approval study included patients who   show the rest ...
Final Safety Findings Infection Free Rates

For the overall system, the infection free rates were not significantly different between   show the rest ...
Final Effectiveness Findings For both the Original Surgery Group and the Revision Surgery Group, the 5쳌]year revision free   show the rest ...
Study Strengths and Weaknesses Strengths

An all쳌]comers Registry쳌]based study with large, representative study sample



Weaknesses

There is no formal follow쳌]up plan, which   show the rest ...
Recommendations for Labeling Changes Labeling change recommended to include long쳌]term safety and effectiveness data from the registry쳌]based study.   show the rest ...


Registry AMS MC-0611 Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
1 year report 10/13/2007 10/15/2007 Overdue/Received
2 year report 10/12/2008 10/10/2008 On Time
3 year report 10/12/2009 10/13/2009 Overdue/Received
48 month interim report 10/12/2010 10/12/2010 On Time
5 year report 10/12/2011 10/12/2011 On Time
6 year report - final report 01/12/2013 01/14/2013 Overdue/Received

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