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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 P090016
Current Protocol Accepted 03/08/2013
Study Name Concentration and Molecular Weight
Study Status Completed
General Study Protocol Parameters
Study Design Bench/Lab Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Detailed Study Protocol Parameters
Study Design Description Bench/Lab study to evaluate the concentration and molecular weight distribution of low molecular weight hyaluronic   show the rest ...
Study Population Description Not applicable. This is a bench/lab study.
Sample Size Not applicable. This is a bench/lab study.
Data Collection Not applicable. This is a bench/lab study.
Followup Visits and Length of Followup Not applicable. This is a bench/lab study.
Final Study Results
Actual Number of Patients Enrolled n/a - bench study
Actual Number of Sites Enrolled n/a - bench study
Patient Followup Rate The concentration and molecular weight distribution of low MW hyaluronic acid (HA) fragments in three   show the rest ...
Final Safety Findings ¿The study results fulfilled the second condition of approval: the sponsor should provide ¿results of   show the rest ...
Study Strengths and Weaknesses A. Strengths:

¿The evaluation methods used in this study effectively evaluated the concentration and distribution of   show the rest ...
Recommendations for Labeling Changes No labeling changes are recommended because no unexpected findings were reported and no additional information   show the rest ...

Concentration and Molecular Weight Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
interim report (six month) 05/14/2012 05/25/2012 Overdue/Received
one year report 11/13/2012 11/09/2012 On Time
18 month report 05/14/2013 05/14/2013 On Time
two year report 11/13/2013 11/07/2013 On Time
three year report-final report 11/13/2014 11/12/2014 On Time

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