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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 P020014 S012
Most Recent Protocol Version Approved 06/15/2007
Study Name ESS-305
Study Status Completed
General Study Protocol Parameters
Study Design Cross-Sectional Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is an observational cohort study. A new cohort of patients and physicians will be   show the rest ...
Study Population Description Study population is as per device indication. This device is indicated for permanent birth control   show the rest ...
Sample Size 657 women enrolled - protocol states 20 sites enrolled patients
Data Collection Study endpoints include: (1) bilateral micro-insert placement rate, (2) identification of factors predictive of micro-insert   show the rest ...
Followup Visits and Length of Followup N/A
Final Study Results
Actual Number of Patients Enrolled 584 women
Actual Number of Sites Enrolled 76
Patient Followup Rate 81.60%
Final Safety Findings The sponsor reported only 6 adverse events occurred during and after the Essure placement procedure   show the rest ...
Study Strengths and Weaknesses The study is well designed to evaluate the placement rate among newly trained physicians at   show the rest ...
Recommendations for Labeling Changes Update labeling with the results of the study in the context of patient and physician labeling.


ESS-305 Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
6 month report 12/14/2007 12/14/2007 On Time
1 year report 06/14/2008 06/17/2008 Overdue/Received
18 month report 12/13/2008 12/15/2008 Overdue/Received
Final Report 06/14/2009 06/16/2009 Overdue/Received

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