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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 P030002 S027
Current Protocol Accepted 02/09/2016
Study Name OSB Lead-New Enrollment 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 The objective of this post approval safety study is to evaluate the incidence of

IOL vaulting   show the rest ...
Study Population Description All subjects who meet eligibility criteria will be consecutively offered enrollment

into the trial until a   show the rest ...
Sample Size The study will enroll up to approximately 686 eyes:

A final sample size of 500 eyes   show the rest ...
Data Collection The study endpoint is the incidence of clinically significant IOL vaulting (ie,

position change such as   show the rest ...
Followup Visits and Length of Followup Study participants will be followed for 3 years postoperatively.

OSB Lead-New Enrollment Study Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report 11/18/2013 01/28/2014 Overdue/Received
one year report 05/20/2014 06/25/2014 Overdue/Received
18 month report 11/18/2014 11/24/2014 Overdue/Received
two year report 05/20/2015 05/20/2015 On Time
three year report 06/18/2016 06/17/2016 On Time
four year report 05/19/2017    
five year report 05/19/2018    

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