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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 P000040 S014
Most Recent Protocol Version Approved 04/23/2012
Study Name Genesys HTA Post Approval Registry
Study Status Completed
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description A Multi-center, Single-arm, Prospective Registry of the Genesys HTATM System for the Treatment of Menorrhagia   show the rest ...
Study Population Description All women treated with the Genesys HTATM System under the approved indications for use who   show the rest ...
Sample Size 1312 subjects at a maximum of 100 clinical sites
Data Collection Rate of clinically significant burns (primary)

Rate of technical complaints with the system (secondary)

Assessment of serious   show the rest ...
Final Study Results
Actual Number of Patients Enrolled 1,014
Actual Number of Sites Enrolled 18
Patient Followup Rate 91.8% (931/1,014)
Final Safety Findings There have been 4 burn events: 3 non-clinically significant burns and 1 clinically significant burn   show the rest ...
Final Effectiveness Findings There was no effectiveness endpoint per se. The secondary objective of the study was to   show the rest ...
Study Strengths and Weaknesses This study had an adequate sample size that was large enough to study key safety issues.
Recommendations for Labeling Changes No labeling changes are recommended


Genesys HTA Post Approval Registry Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
six month report 10/22/2010 10/22/2010 On Time
one year report 04/23/2011 04/22/2011 On Time
18 month report 10/22/2011 10/24/2011 Overdue/Received
two year report 04/22/2012 04/18/2012 On Time
Final PAS Report 10/22/2012 10/19/2012 On Time

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