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 SHOULD COLLECT AND REPORT TO THE AGENCY ON AN ANNUAL BASIS CLINICAL OUTCOMES THROUGH
5 YEARS POST-PROCEDURE ON AT LEAST 80% OF PATIENTS ENROLLED (EXCLUDING THOSE DISCONTINUED DUE TO DEATH) FROM SPIRIT FIRST, SPIRIT II, SPIRIT III, AND SPIRIT IV. WHEN APPROPRIATE OR AS REQUESTED BY FDA, YOU SHOULD SUBMIT PMA SUPPLEMENTS REQUESTING APPROVAL TO UPDATE YOUR INSTRUCTIONS FOR USE (IFU) TO INCLUDE THESE DATA. 2. YOU SHOULD COLLECT CLINICAL DATA ON THE IMPLANTATION OF THE PMA-APPROVED, COMMERCIALLY-DISTRIBUTED XIENCE V PRODUCT IN THE U.S. THE TRIAL SHOULD BE STATISTICALLY POWERED TO EVALUATE THE ANNUAL RATES OF STENT THROMBOSIS, AND THE RATE OF CARDIAC DEATH PLUS MYOCARDIAL INFARCTION (MI) THROUGH FIVE YEARS IN PATIENTS TREATED WITH THE XIENCE V STENT ACCORDING TO ITS LABELED INDICATIONS. THESE DATA ARE NEEDED TO EVALUATE WHETHER THE RATE OF STENT THROMBOSIS PLATEAUS OR INCREASES OVER TIME, AND TO EVALUATE THE IMPACT OF STENT THROMBOSIS ON RATES OF CARDIAC DEATH AND MI. THESE DATA ARE ALSO NEEDED TO EVALUATE THE POTENTIAL FOR RARE ADVERSE EVENTS RELATED TO THE DRUG SUBSTANCE AND/OR DRUG CARRIER THAT COULD NOT BE DETECTED IN YOUR INITIAL CLINICAL TRIALS. YOU SHOULD ALSO COLLECT ADDITIONAL DATA ON CLINICAL OUTCOMES (INCLUDING TARGET LESION REVASCULARIZATION RATES AT 12 MONTHS POST-IMPLANTATION) ASSOCIATED WITH USE OF THE XIENCE V 4.0 MM DIAMETER STENT TO CONFIRM THE OUTCOMES OBSERVED IN THE 4.0 MM ARM OF THE SPIRIT III TRIAL. YOU HAVE PROPOSED COLLECTING THESE DATA FROM AT LEAST 5000 PATIENTS ENROLLED IN THE XIENCE V USA POSTMARKET REGISTRY. FDA AGREES THAT THE REGISTRY PROTOCOL SUBMITTED IN SUPPLEMENT 97 OF YOUR INVESTIGATIONAL DEVICE EXEMPTION (IDE), G050050, WITH THE PLANNED MODIFICATIONS TO THE STATISTICAL ANALYSIS PLAN, IS ACCEPTABLE. PLEASE PROVIDE PROGRESS REPORTS AT 6, 12, 18, AND 24 MONTHS AND ANNUALLY THEREAFTER THROUGH 5 YEARS WITH DATA FROM YOUR U.S. REGISTRY....(SEE APPROVAL ORDER FOR ADDITIONAL STUDY INFORMATION)
