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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 P030016
Current Protocol Accepted 12/22/2005
Study Name OSB Lead-Axial Lengths
Study Status Completed
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 Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This clinical study is a prospective cohort, two-center, non-randomized study. The objective of this clinical   show the rest ...
Study Population Description Study population is as per device indication: This device is indicated for adults 21-45 years   show the rest ...
Sample Size 30 eyes (30 patient)
Data Collection Axial length of the eye
Followup Visits and Length of Followup baseline & 1 month
Final Study Results
Actual Number of Patients Enrolled 30
Actual Number of Sites Enrolled 2
Patient Followup Rate 100%
Final Safety Findings 24 of the 30 patients were from Site 1 and 6 patients were from site   show the rest ...
Study Strengths and Weaknesses One of the strenghts is that this was a prospective study. However, the length of   show the rest ...
Recommendations for Labeling Changes Labeling should be updated to include a summary of the post-approval study design, results, and   show the rest ...

OSB Lead-Axial Lengths Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
Final Report 08/03/2009 09/03/2009 Overdue/Received
Interim Report 08/03/2009 08/04/2009 Overdue/Received

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