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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 P050034
Current Protocol Accepted 10/13/2010
Study Name Premarket Cohort IMT-002-LTME
Study Status Completed
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) Yes
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The ¿LTME¿ Study is designed to further evaluate the safety of the participants of IMT-002   show the rest ...
Study Population Description

Patients who participated in the IMT-002 trial will be contacted and asked to participate in   show the rest ...
Sample Size The sponsors anticipate a cohort of approximately 70 IMT-002 subjects enrolling at approximately 20 participating   show the rest ...
Data Collection The clinical parameters to be evaluated at study visits in both eyes are:

Best spectacle-corrected distance   show the rest ...
Followup Visits and Length of Followup Subjects will be examined at the time of entry into the study, and then will   show the rest ...
Final Study Results
Actual Number of Patients Enrolled 51
Actual Number of Sites Enrolled 20
Patient Followup Rate 94%
Final Safety Findings The cohort that went to the LTME study and the cohort without going to the   show the rest ...
Final Effectiveness Findings n/a
Study Strengths and Weaknesses The study was an extended follow-up study of the IDE study cohort. The final follow-up   show the rest ...
Recommendations for Labeling Changes Yes, update label with 5-years post-op data .


Premarket Cohort IMT-002-LTME Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
6 month report 12/30/2010 12/22/2010 On Time
1 year report 07/01/2011 06/29/2011 On Time
18 month report-final report 01/31/2012 01/27/2012 On Time

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