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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 P030016
Current Protocol Accepted 06/08/2012
Study Name Adverse Event Study
Study Status Progress Adequate
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 Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective Registry with patients reporting outcomes
Study Population Description The device is indicated for adults 21-45 years of age:to correct myopia ranging from -3.0   show the rest ...
Sample Size 3,000 eyes will be enrolled

2,000 treated eyes needed with 5-year data

Data Collection Corneal edema, cataract, chronic uveitis, glaucoma, retinal detachment, second surgery, and other complications assessed by   show the rest ...
Followup Visits and Length of Followup 6, 12, 18, 24, 36,48, and 60 months after implantation


Adverse Event Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
1 year report 03/30/2007 03/30/2007 On Time
2 year report 05/30/2009 04/30/2009 On Time
3 year report 12/22/2009 04/29/2010 Overdue/Received
4 year report 12/22/2010 03/07/2011 Overdue/Received
report 07/31/2012 07/27/2012 On Time
annual report 07/31/2013 08/01/2013 Overdue/Received
annual report 08/01/2014 08/01/2014 On Time
annual report 07/31/2015    

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