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.
Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v
Silver Spring, MD
20993-0002
This study will provide long-term follow-up of forty-three subjects from the premarket cohort that have
been designated as High Risk.
Study Population Description
This device is indicated for use in patients with a complex VSD of significant size
to warrant closure (large volume left to right shunt, pulmonary hypertension and/or clinical symptoms of congestive heart failure) who are considered to be at high risk for standard transatrial or transarterial surgical closure based on anatomical conditions and/or based on overall medical condition.
Sample Size
43 patients, 21 sites
Data Collection
Safety endpoints include adverse events.
Followup Visits and Length of Followup
Annual office visits were required out to 5 years.
Final Study Results
Actual Number of Patients Enrolled
43
Actual Number of Sites Enrolled
38
Patient Followup Rate
24%
Final Safety Findings
A total of 35 overall events were reported in 20 of 43 subjects (46.5%). The
most frequently reported event was hypotension which was reported in 11.6% of subjects (5 reports in 5 of 43 subjects).
Study Strengths and Weaknesses
Strengths: Lessons learned on requesting for long term follow-up consent at tiem of IDE enrollment
