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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 P890055 S026
Most Recent Protocol Version Approved 03/15/2011
Study Name Leachables Study
Study Status Progress Adequate
General Study Protocol Parameters
Study Design Bench/Lab Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source Other Data Source
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The non-clinical study includes extraction and leachables testing. There are no stated hypotheses.
Study Population Description Not applicable. This is a bench/lab study.
Sample Size Not applicable. This is a bench/lab study.
Data Collection In order to determine the endpoints extraction testing and leachable testing will be performed.
Followup Visits and Length of Followup Not applicable. This is a bench/lab study.


Leachables Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
six month report 06/17/2011 07/15/2011 On Time
one year report 12/17/2011 12/15/2011 On Time
18 month report 06/16/2012 06/15/2012 On Time
two year report 12/16/2012 12/17/2012 Overdue/Received
three year report 12/16/2013 12/16/2013 On Time
four year report 12/16/2014    
five year report 12/16/2015    
six year report 12/15/2016    
seven year report 12/15/2017    
eight year report 12/15/2018    
102 month report/final report 06/15/2019    

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