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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 P080025
Most Recent Protocol Version Approved 03/14/2011
Study Name FI-PAS
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
Detailed Study Protocol Parameters
Study Design Description Prospective, non-randomized, multicenter study
Study Population Description Study subjects are individuals enrolled in IDE study with a history of chronic fecal incontinence   show the rest ...
Sample Size 285 subjects, 12 sites
Followup Visits and Length of Followup 5 years post implant

Yearly up until at least 5 years post implant

Final Study Results
Actual Number of Patients Enrolled 120
Actual Number of Sites Enrolled 13
Patient Followup Rate 60% (72/120)(Rate included 14 subjects who were lost due to death of Principal Investigator and

5   show the rest ...
Final Safety Findings There were no specific study safety endpoints in this post approval study. Safety was monitored   show the rest ...
Final Effectiveness Findings Primary Endpoint: Incontinent Episoides ( ¡Ý50% improvement from baseline): Proportion of Successes: 69% (95%CI- 60%-77%),   show the rest ...
Study Strengths and Weaknesses Strength: Prospective hypothesis driven study, high level of quality control, multiple effectiveness outcomes evaluated including   show the rest ...
Recommendations for Labeling Changes yes


FI-PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
six month report 09/12/2011 09/15/2011 Overdue/Received
one year report-final report 04/12/2012 04/13/2012 Overdue/Received

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