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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 P970051 S028
Current Protocol Accepted 03/01/2005
Study Name Adult 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 The study was conducted as a within-subject repeated-measures experiment (each subject served as his or   show the rest ...
Study Population Description Study subjects were to be 18 years of age and older, with post-lingual onset of   show the rest ...
Sample Size 50 patients
Data Collection Tests of auditory speech perception were the primary outcome: Hearing in Noise Test (HINT) sentences,   show the rest ...
Followup Visits and Length of Followup at week 0, 3, 5, 8, 10, 12, 14, 16, 24, 12-month
Final Study Results
Actual Number of Patients Enrolled 76 patients
Actual Number of Sites Enrolled 14
Patient Followup Rate 71%
Final Safety Findings There were progressive improvements in mean percent correct scores across the test intervals for CNC   show the rest ...
Study Strengths and Weaknesses Prospective Randomized Controlled Study
Recommendations for Labeling Changes Label needs to be updated to refelct the findings of the Adult PAS study


Adult Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
1 year Report 03/01/2006 03/08/2006 Overdue/Received
18 month report 09/01/2006 10/02/2006 Overdue/Received
2 year report 03/01/2007 03/14/2007 Overdue/Received
Final Report (Adult Study) 09/01/2007 08/31/2007 On Time

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