• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies

  • Print
  • Share
  • E-mail

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

Show All Studies
Suggest Enhancement / Report Issue | Export to ExcelExport to Excel
Application Number P010047
Current Protocol Accepted 03/16/2015
Study Name OSB Lead-Long Term Safety
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 Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Prospective, non-randomized, controlled observational study with a ProGel PALS group and a comparison group of   show the rest ...
Study Population Description Newly enrolled consecutive patients post-approval study population
Sample Size 400 evaluable subjects (267 ProGEL Sealant + 133 Control) at up to 30 U.S. sites.

Data Collection Primary Endpoints:

The study will include evaluation of twelve safety endpoints (i.e. specified AE). These include:

1. Pneumothorax

2. Air   show the rest ...
Followup Visits and Length of Followup 5 years

30-day and 90-day follow-up visits are scheduled for study assessments

OSB Lead-Long Term Safety Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
1 year report 01/14/2011 01/14/2011 On Time
18 month report 07/15/2011 07/14/2011 On Time
2 year report 01/14/2012 01/13/2012 On Time
rqst to change report dates 10/16/2012 10/16/2012 On Time
3 year report 01/13/2013 01/14/2013 Overdue/Received
4 year report 01/13/2014 01/13/2014 On Time
5 year report 01/13/2015 01/12/2015 On Time
6 year report 01/13/2016 01/12/2016 On Time
Final Report 04/01/2016 04/01/2016 On Time
7 year report 01/13/2017    

Show All Studies