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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 P050034
Current Protocol Accepted 01/27/2015
Study Name OSB Lead-IMT PAS 01 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 the study is to assess the safety of the

intraocular telescope as measured   show the rest ...
Study Population Description The intraocular telescope is indicated for monocular implantation to improve vision in patients greater than   show the rest ...
Sample Size The sample size of 770 Subjects was calculated under the following assumptions: Two-sided type I   show the rest ...
Data Collection The clinical parameters to be evaluated in both eyes at study visits are:

1. Best spectacle-corrected   show the rest ...
Followup Visits and Length of Followup 5 years

¿Study entry


¿Postoperative day 1 (18-36 hours)

¿Day 7 (+/- 2 days)

¿1 Month (+/- 1 week)

¿3 Months (+/- 1 month)

¿6   show the rest ...

OSB Lead-IMT PAS 01 New Enrollment Study Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
6 month report 12/30/2010 12/22/2010 On Time
1 year report 07/01/2011 06/15/2011 On Time
18 month report 12/30/2011 12/27/2011 On Time
2 year report 06/30/2012 07/02/2012 Overdue/Received
3 year report 06/30/2013 06/24/2013 On Time
4 year report 06/30/2014 07/03/2014 Overdue/Received
5 year report 06/30/2015 06/26/2015 On Time
6 year report 06/30/2016 07/01/2016 Overdue/Received

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