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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.


Contact Information

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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Application Number P930016 S025
Current Protocol Accepted 04/02/2008
Study Name OSB Lead-Star 4 Monovision Lasik
Study Status Other
Study Progress Reason Other reason
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 Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study will be a multi-center, single-arm prospective Post-Approval Study in which a subject's pre-operative   show the rest ...
Study Population Description Study population is as per approved indications: This device uses a 6.0 mm optical zone,   show the rest ...
Sample Size 525 subjects
Data Collection The DataFax system will be utilized to transmit CRF and questionnaire data to AMO. Requests   show the rest ...
Followup Visits and Length of Followup baseline & 6 month

OSB Lead-Star 4 Monovision Lasik Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
1 year report 07/10/2008 07/14/2008 Overdue/Received
18 month report 01/08/2009 01/21/2009 Overdue/Received
2 year report 07/10/2009 02/04/2010 Overdue/Received

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