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
Subjects who have completed participation in the Investigational Phase of this study and who have
the Argus II device still implanted are eligible for enrollment in the Post-Approval Phase of this study.
Sample Size
N = 29. Fourteen (14) subjects were enrolled in the Investigational Phase of the study.
One of these 14 subjects was explanted, which leaves a maximum of 13 subjects in the U.S. eligible for the post-approval phase of this study. An additional 16 subjects were enrolled in a similar study in Europe. All 16 of these subjects are eligible for participation in the post-approval phase of the study.
Data Collection
The primary endpoint of the post-approval phase is safety (i.e. the rates of adverse events).
The secondary endpoint of the post-approval phase the long-term reliability of the Argus II implant.
Followup Visits and Length of Followup
Extend the subjects? overall participation in the study to 10 years post-implant.
During year 5 to
7, every six month; from year 8 to 10 annually. Note the examinations are not exactly the same prior to year 7 and thereafter, because the study undergoing was extended to year 7.
Extended f/u of the Argus II Feasibility Study
Schedule
