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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 P040048
Current Protocol Accepted 06/28/2006
Study Name Long term
Study Status Revised/Replaced Study
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 No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The post-approval study is a prospective, multi-center, uncontrolled cohort study of subjects in whom the   show the rest ...
Study Population Description Study population is as per device indication and it includes: age from 21 to 80   show the rest ...
Sample Size 250 patients
Data Collection Endpoints not mentioned
Followup Visits and Length of Followup During the first five years of the study clinical, radiographic, and subject self assessment information   show the rest ...


Long term Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
6 month report 12/27/2006 01/08/2007 Overdue/Received
1 year report 06/28/2007 06/26/2007 On Time
18 month report 12/27/2007 12/26/2007 On Time
2 year report 07/24/2008 07/30/2008 On Time
3 year report 06/27/2009 06/23/2009 On Time

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