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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 H060002
Current Protocol Accepted 12/16/2014
Study Name OSB Lead-IBV Valve
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 study is a prospective observational study to collect safety information about the IBV Valve   show the rest ...
Study Population Description Patients with prolonged air leaks of the lung, or significant air leaks that are likely   show the rest ...
Sample Size 32 patients will be enrolled at up to 15 clinical sites.
Data Collection The safety endpoints include the total number, rate, type, timing, duration, severity and relationship to   show the rest ...
Followup Visits and Length of Followup The duration of follow-up is a maximum of 6 weeks.
Final Study Results
Actual Number of Patients Enrolled 39
Actual Number of Sites Enrolled 11
Patient Followup Rate 100% (32/32 as per protocol)
Final Safety Findings No unanticipated adverse device effects (UADE) have been reported for the Spiration PAS.

SAE: There have   show the rest ...
Final Effectiveness Findings Of the 32 subjects who received valves for treatment of air leak, 30 (94%) showed   show the rest ...
Study Strengths and Weaknesses Strength: 100% follow-up

Weaknesses: Limited number of female patients (10), small sample size (32), and no   show the rest ...
Recommendations for Labeling Changes The PAS study design, methods and results must be included in the labeling. Additionally, it   show the rest ...

OSB Lead-IBV Valve Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
6 month report 05/01/2009 04/23/2009 On Time
1 year report 11/01/2009 10/21/2009 On Time
18 month report 04/25/2010 04/23/2010 On Time
2 year report 11/01/2010 10/25/2010 On Time
30 month report 04/25/2011 04/25/2011 On Time
36 month report 10/26/2011 10/26/2011 On Time
4 year report 10/23/2012 10/26/2012 Overdue/Received
five year report 10/23/2013 10/28/2013 Overdue/Received
6 year report 11/24/2014 12/02/2014 Overdue/Received
Final Report 02/29/2016 03/01/2016 Overdue/Received

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