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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 P120009
Current Protocol Accepted 08/01/2014
Study Name Nit-Occlud PDA PAS
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 New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Infant: 29 days-2 yrs, Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs
Detailed Study Protocol Parameters
Study Design Description The study is a controlled, prospective, single-arm, multi-center trial with newly enrolled patients.
Study Population Description Patients who have successful Nit-Occlud PDA device implantation
Sample Size 215 patients from up to 20 sites to achieve a sample size of 150 subjects

available   show the rest ...
Data Collection The primary safety endpoint is the serious device and/or procedure related

adverse event rate at 60   show the rest ...
Followup Visits and Length of Followup 5 years

Clinical assessments at 2, 12, 24, 36, 48, and 60 months

Echocardiography at 2, 12,   show the rest ...


Nit-Occlud PDA PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
six month report 02/14/2014 02/21/2014 Overdue/Received
one year report 08/16/2014 08/18/2014 Overdue/Received
18 month report 02/14/2015    
two year report 08/16/2015    
three year report 08/15/2016    
four year report 08/15/2017    
five year report 08/15/2018    

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