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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 P070022
Current Protocol Accepted 07/06/2009
Study Name EASE TRIAL
Study Status Terminated
Study Progress Reason Sponsor withdraws PMA
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 Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study is a continued follow-up of subjects in the premarket EASE trial, a prospective,   show the rest ...
Study Population Description The device is indicated for women who desire permanent birth control (female sterilization) by occlusion   show the rest ...
Sample Size 770 patients, 16 sites
Data Collection Effectiveness endpoint is the pregnancy rate during the three through ten year reliance follow-up period   show the rest ...
Followup Visits and Length of Followup All subjects will be assessed annually in years 3, 4, 5, 6, 7, 8, 9   show the rest ...


EASE TRIAL Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
6 month report 01/15/2010 01/19/2010 Overdue/Received
12 month report 07/06/2010 07/08/2010 Overdue
18 month report 01/04/2011 01/11/2011 Overdue/Received
2 year report 07/06/2011 07/14/2011 Overdue/Received

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