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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 P040050
Most Recent Protocol Version Approved 10/30/2006
Study Name 5 year registry - ROSE
Study Status Progress Adequate
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 Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The Real-Time Observation of Safety and Effectiveness (ROSE) study is a non-randomized, prospective, multi-center, registry   show the rest ...
Study Population Description The study population consists of women at least 18 years of age diagnosed with stress   show the rest ...
Sample Size 275 enrolled patients and maximum of 20 sites
Data Collection The primary endpoints are additional or alternative surgical treatment over a 5-year period and incidence   show the rest ...
Followup Visits and Length of Followup Subjects are followed for 5 years following initial treatment with Macroplastique or until alternative treatment   show the rest ...


5 year registry - ROSE Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
6 month report 04/30/2007 04/26/2007 On Time
1 year registry report 10/30/2007 11/01/2007 Overdue/Received
18 month registry report 04/29/2008 04/29/2008 On Time
2 year registry report 10/29/2008 10/29/2008 On Time
3 year registry report 10/29/2009 10/29/2009 On Time
4 year registry report 10/29/2010 10/29/2010 On Time
5 year registry report 10/29/2011 10/28/2011 On Time
6 year registry report 10/28/2012 10/26/2012 On Time
7 year report 10/28/2013 10/25/2013 On Time
8 year report 10/28/2014    

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