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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 Pediatric Study
Study Status Completed
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 No Control
Analysis Type Descriptive
Study Population Infant: 29 days-2 yrs, Child: 2-12 yrs, Adolescent: 13-18 yrs
Detailed Study Protocol Parameters
Study Design Description This is a multi-center, prospective, single-arm study. It is a was a within-subject self-control experiment   show the rest ...
Study Population Description The study includes patients as per device indication. The device is Intended to restore a   show the rest ...
Sample Size At least 50 patients; up to 5 centers
Data Collection Children under 3 years of age:

* Infant-Toddler Meaningful Auditory Integration Scale (IT-MAIS)

Children 3 to   show the rest ...
Followup Visits and Length of Followup A follow-up evaluation was to take place 1 month post-activation and threshold and comfort levels   show the rest ...
Final Study Results
Actual Number of Patients Enrolled 69 enrolled and implanted patients above 12 months of age
Actual Number of Sites Enrolled 7 centers
Patient Followup Rate 72.50%
Final Safety Findings No unanticipated AEs and 9 complications overall. Type of Complication - Number of occurrences -

Rate   show the rest ...
Study Strengths and Weaknesses Low follow up rate. No controls.
Recommendations for Labeling Changes None


Pediatric Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
Semi-annual report (Pediatric Study) 09/01/2007 08/31/2007 On Time
FINAL Report 04/01/2009 04/01/2009 On Time
Final Report 04/01/2009 07/01/2009 Overdue/Received
Request to withdraw report 05/04/2009 05/04/2009 On Time

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