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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 P050031
Current Protocol Accepted 06/06/2007
Study Name Paragon PAS
Study Status Completed
General Study Protocol Parameters
Study Design Active Surveillance
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 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 The study is a retrospective study design where a randomly selected, stratified sample of 200   show the rest ...
Study Population Description Study population is as per approved device indication: The lenses are indicated for use in   show the rest ...
Sample Size Approximately 1,000 pediatrics and 1,000 Adults. A total of 2,000 patient-years had to be accrued
Data Collection Cases of microbial keratitis (MK)
Followup Visits and Length of Followup On average each subject was to be followed for 1 year
Final Study Results
Actual Number of Patients Enrolled 1317
Actual Number of Sites Enrolled 86
Patient Followup Rate 84.8%
Final Safety Findings Incidence of microbial keratitis was the main study endpoint.

A total of 2,599 patient-years of   show the rest ...
Final Effectiveness Findings Not applicable
Study Strengths and Weaknesses Due to the nature of retrospective study design, the study was conducted in relatively short   show the rest ...
Recommendations for Labeling Changes Yes.

The recommended labeling change includes a summary of the 522 study including: introduction, study   show the rest ...


Paragon PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
Status Report 09/05/2008 09/05/2008 On Time

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