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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 P980022 S012
Most Recent Protocol Version Approved 12/27/2006
Study Name PXX/GS041/A
Study Status Completed
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Study involve follow-up of premarket cohort (Y/N) No
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study is a randomized controlled trial, in which one arm receives the device with   show the rest ...
Study Population Description Study Population: Patients aged 18 to 65 years, previously diagnosed with type 1 diabetes, and   show the rest ...
Sample Size 78 patients, 4 sites
Data Collection The clinical endpoints to be measured consist of capillary blood glucose concentration as measured by   show the rest ...
Followup Visits and Length of Followup After enrollment, subjects will be followed by phone calls on day 3, day 18, and   show the rest ...
Final Study Results
Actual Number of Patients Enrolled 78
Actual Number of Sites Enrolled 4
Patient Followup Rate 80%
Final Safety Findings A total of five adverse events were reported across 4 subjects during the study. All   show the rest ...
Study Strengths and Weaknesses Strength: The study was designed as a randomized controlled trial.
Recommendations for Labeling Changes There were no recomendations made for labeling changes.


PXX/GS041/A Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
6 month report 06/27/2007 06/19/2007 On Time
1year report 12/30/2007 12/20/2007 On Time
18 month report 06/29/2008 06/17/2008 On Time
Final Report 10/01/2008 09/30/2008 On Time

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