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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 P040050
Most Recent Protocol Version Approved 10/30/2006
Study Name Enhanced Surveillance
Study Status Completed
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 Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Enhanced surveillance to rapidly assess potential adverse events related to the use of Macroplastique following   show the rest ...
Study Population Description All patients receiving the device. The device is indicated for women who have stress urinary   show the rest ...
Sample Size N/A
Data Collection Information on patient characteristics, treatment and retreatment, and onset, severity, and resolution of the event   show the rest ...
Followup Visits and Length of Followup N/A
Final Study Results
Actual Number of Patients Enrolled N/A
Actual Number of Sites Enrolled N/A
Patient Followup Rate 87%
Final Safety Findings No serious adverse events were identified by the Enhanced Surveillance Program since device was launched   show the rest ...
Study Strengths and Weaknesses Enhanced surveillance system with high response rate from participating physicians.
Recommendations for Labeling Changes Update labeling to reflect the results of the Post-Approval Study


Enhanced Surveillance Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
1 year enhanced surveillance report 10/30/2007 11/01/2007 Overdue/Received
18 month enhanced surveillance report 04/29/2008 04/29/2008 On Time
2 year enhanced surveillance report 10/29/2008 10/29/2008 On Time

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