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 is a prospective cohort study desgined to extend the follow-up patients enrolled in the
premarket study. Patients will be followed for 18-months.
Study Population Description
This device is indicated for subdermal implantation for restoration and/or correction of the signs of
facial fat loss (lipoatrophy) in people with human immunodeficiency virus (HIV). The study population includes patients with facial lipoatrophy due to antiretroviral therapy for human immunodeficiency virus.
Sample Size
98 patients, 3 sites
Data Collection
At the 18-month visit, subjects had a Global Aesthetic Improvement Scale assessment, photograph, skin thickness
measurement, patient satisfaction assessment, CD4+ cell count and viral load test, and recording of adverse events and medications.
Followup Visits and Length of Followup
The study required 18 month follow-up. As a part of the post-market requirement, study participants
