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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 P050010
Most Recent Protocol Version Approved 08/14/2006
Study Name PRODISC-L Long Term Study
Study Status Completed
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Study involve follow-up of premarket cohort (Y/N) Yes
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is continuation of the IDE study, which was a multi-center, prospective, randomized, controlled clinical   show the rest ...
Study Population Description Study population is as per device indication. The study population consists of all patients from   show the rest ...
Sample Size A total of 286 patients (161 randomized investigational subjects, 75 randomized control subjects, and 50   show the rest ...
Data Collection The outcome measures in the PAS include patient self-assessment on Oswestry score, SF-36, Pain and   show the rest ...
Followup Visits and Length of Followup The subjects were followed at 6 weeks, 3 months, 6 months, 12 months, 18 months   show the rest ...
Final Study Results
Actual Number of Patients Enrolled 161 randomized investigational subjects, 50 training investigational subjects, and 75 control subjects. Overall 286 patients   show the rest ...
Actual Number of Sites Enrolled 17 sites were enrolled for the Post-Approval Study.
Patient Followup Rate 60.2%, 60.1% and 82.5% were the overall follow up rates at 36, 48, and 60 months, respectively.
Final Safety Findings During the 3 years of the PAS, there were several AEs with higher occurrence in   show the rest ...
Final Effectiveness Findings At month 60 non-inferiority was demonstrated for Overall Success (p=0.0099) and Overall Success (Secondary Analyses)   show the rest ...
Study Strengths and Weaknesses The main strength of the study is the randomized design. The main weakness of the   show the rest ...
Recommendations for Labeling Changes Yes.


PRODISC-L Long Term Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
1 year report 12/24/2007 12/21/2007 On Time
2 year report 06/09/2009 06/10/2009 Overdue/Received
Final Report 09/27/2010 09/20/2010 On Time

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