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.
Enhanced surveillance to rapidly assess potential adverse events related to the use of Macroplastique following
its launch in the U.S. marketplace. It involved the active solicitation of information on adverse events associated with Macroplastique from all U.S. physician customers on a quarterly basis for two years following PMA approval.
Study Population Description
All patients receiving the device. The device is indicated for women who have stress urinary
incontinence due to poorly functioning urethral sphincter muscles.
Information on patient characteristics, treatment and retreatment, and onset, severity, and resolution of the event
are to be obtained only if the customers have reportable events.
Followup Visits and Length of Followup
Final Study Results
Actual Number of Patients Enrolled
Actual Number of Sites Enrolled
Patient Followup Rate
Final Safety Findings
No serious adverse events were identified by the Enhanced Surveillance Program since device was launched
to market in the U.S through March 2008. The data for enhanced surveillance was collected for 2 years as per approval order.
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