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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 P000032 S028
Most Recent Protocol Version Approved 03/27/2009
Study Name Her Option 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 Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective study to continue follow-up of the premarket cohort. As per approval   show the rest ...
Study Population Description This device is a closed-cycle cryosurgical device intended to ablate the endometrial lining of the   show the rest ...
Sample Size All premarket subjects
Followup Visits and Length of Followup 3 years
Final Study Results
Actual Number of Patients Enrolled 106 women
Actual Number of Sites Enrolled 7
Patient Followup Rate At the end of the three year follow-up 51 participants were followed out of 82 treated (62.2%)
Final Safety Findings

Of the 82 subjects treated, 54 subjects (65.9%) were free of any treatment-related complications or   show the rest ...
Final Effectiveness Findings

Long term success rates were calculated for the 2-year and 3-year visits and demonstrate a   show the rest ...
Study Strengths and Weaknesses This multicenter study was well planned and conducted to evaluate the effectiveness of this surgical   show the rest ...
Recommendations for Labeling Changes Labeling should be updated with the results of the study at all evaluation follow-up times   show the rest ...


Her Option PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
Final Report 03/27/2010 01/28/2011 Overdue/Received

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