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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 P040003 S006
Most Recent Protocol Version Approved 04/19/2010
Study Name Exablate 2100 Type 1.0
Study Status Completed
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The primary goal of the study is to evaluate the incidence of post-procedure significant leg   show the rest ...
Study Population Description Pre or peri-menopausal women who are not pregnant or breastfeeding, ages 18 and over, are   show the rest ...
Sample Size A total of one hundred and fifteen (115) patients will be enrolled and treated. This   show the rest ...
Data Collection Safety data will be collected, including the type, frequency, and severity of adverse events (see   show the rest ...
Followup Visits and Length of Followup Patients will be followed at one week and one month.
Final Study Results
Actual Number of Patients Enrolled 115 subjects enrolled and treated
Actual Number of Sites Enrolled 7
Patient Followup Rate 94% at 1-month
Final Safety Findings There was a substantially higher occurrence of pain in the post-approval study (PAS) compared to   show the rest ...
Final Effectiveness Findings No effectiveness endpoints in this study
Study Strengths and Weaknesses High follow-up rate of 94%.

Multi-center design increases representativeness of the study sample.

Limitations

The high screen failure   show the rest ...
Recommendations for Labeling Changes Yes


Exablate 2100 Type 1.0 Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
6 month report 09/21/2010 10/20/2010 Overdue/Received
1 year report 03/23/2011 04/15/2011 Overdue/Received
18 month report 09/21/2011 09/21/2011 On Time
2 year report 03/22/2012 04/04/2012 Overdue/Received
3 year report-final report 03/22/2013 04/12/2013 Overdue/Received

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