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.
Nicole Jones
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4108
Silver Spring, MD
20993-0002
1. YOU HAVE AGREED TO CONDUCT THE FOLLOWING STUDIES AND TO REPORT ON THESE STUDIES EVERY
6 MONTHS FOLLOWING PMA APPROVAL UNTIL COMPLETION OF THE STUDIES: YOU HAVE AGREED TO PERFORM A LONG-TERM FOLLOW-UP STUDY ON AT LEAST 305 PATIENTS. THE GOALS OF THIS FOLLOW-UP STUDY ARE TO EVALUATE THE LONGER-TERM SAFETY AND EFFECTIVENESS OF THE XACT CAROTID STENT SYSTEM AND EMBOSHIELD EMBOLIC PROTECTION SYSTEM THROUGH THREE YEARS OF IMPLANTATION. AT EACH ANNUAL VISIT, A CLINICAL EXAMINATION, A CAROTID DUPLEX ULTRASOUND, AND A NEUROLOGICAL EXAM (NIHSS) WILL BE CONDUCTED. CLINICAL DATA WILL BE RECORDED ON THE CORRESPONDING CASE REPORT FORMS (CRFS). DIAGNOSTIC STUDIES ON PATIENTS IN THIS COHORT WILL CONTINUE TO BE EVALUATED BY THE CORE LABORATORY. ALL DATA WILL BE MONITORED, ENTERED INTO A DATABASE, ANALYZED AND SUBMITTED IN REPORTS TO THE FDA AND A FINAL REPORT WILL BE SUBMITTED AFTER COMPLETION OF THE FOLLOW-UP AND ANALYSIS. THIS FOLLOW-UP PROPOSAL WILL ALLOW AN EVALUATION OF ADVERSE EVENTS, NEUROLOGICAL EVENTS, AND PERCENT STENOSIS. YOU HAVE AGREED TO CONDUCT A POST-APPROVAL STUDY(IES) THAT INCLUDES AT LEAST 1500 SEQUENTIALLY ENROLLED PATIENTS FROM UP TO 150 GEOGRAPHICALLY DISBURSED SITES. THIS STUDY WILL FOLLOW ALL 1500 PATIENTS FOR 30 DAYS, AND 500 PATIENTS OUT TO 12 MONTHS. THE POST-APPROVAL STUDY WILL ENROLL PATIENTS FROM HIGH, MODERATE AND LOW VOLUME CENTERS AND TREATED BY PHYSICIANS THAT REPRESENT GROUP 1, 2, AND 3 TRAINING. IMAGING DATA, THAT IS, FOLLOW-UP ULTRASOUND OR ANGIOGRAPHIC ASSESSMENTS, WHEN PERFORMED, WILL BE REVIEWED BY A CORE LABORATORY. STROKE SCALE ASSESSMENTS WILL BE CONDUCTED IN ADDITION TO THE PROPOSED INDEPENDENT NEUROLOGICAL ASSESSMENTS. THE ENDPOINT FOR THE 1500 PATIENTS ENROLLED WILL BE A 30-DAY COMPOSITE DEATH, STROKE AND MYOCARDIAL INFARCTION (MI). A PRE-OPERATIVE, DISCHARGE AND 30-DAY INDEPENDENT NEUROLOGICAL ASSESSMENT FOR ALL PATIENTS AND ASSESSMENT OF ALL DEVICE RELATED ADVERSE EVENTS WILL BE CONDUCTED....
