Post-Approval Studies

Post-Approval Studies

• 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.

Links

• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Webpage FAQs
• IRB Letter from Dr. Schultz (dated 2/9/09)

Contact Information

Nicole Jones
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4108
Silver Spring, MD
20993-0002

Phone: (301) 796-6062
Fax: (301) 847-8140
nicole.jones@fda.hhs.gov

Show All Studies Export to Excel Application Number Post-Approval Study Commitment Study Name Protocol Approved Study Population Study Status P070014 1. YOU WILL COLLECT AND REPORT TO THE AGENCY CLINICAL OUTCOMES THROUGH 3 YEARS POST-PROCEDURE ON ALL PATIENTS ENROLLED (EXCLUDING THOSE DISCONTINUED DUE TO DEATH) IN THE RESILIENT TRIAL. YOU SHOULD SUBMIT PMA SUPPLEMENTS REQUESTING APPROVAL TO UPDATE YOUR IFU TO INCLUDE THE DATA COLLECTED AFTER COMPLETION OF 2 YEAR AND 3 YEAR FOLLOW-UP. 2. YOU WILL COLLECT INFORMATION IN A CLINICAL STUDY ON THE IMPLANTATION OF THE COMMERCIALLYDISTRIBUTED LIFESTENT FLEXSTAR AND FLEXSTAR XL VASCULAR STENTS. YOU HAVE AGREED TO CONDUCT THE CONTINUUM (CONTINUOUS INFRA-INGUINAL STENTING USING THE FLEXSTAR AND FLEXSTAR XL ULTRA LONG METALLIC SELF-EXPANDING STENT SYSTEMS) POST-APPROVAL STUDY THAT WILL INCLUDE AT LEAST 170 NEWLY AND SEQUENTIALLY ENROLLED PATIENTS FROM UP TO 20 GEOGRAPHICALLY DISBURSED SITES. THE PRIMARY OBJECTIVE OF THE STUDY IS TO PROVIDE CONFIRMATORY EVIDENCE OF SAFETY AND EFFECTIVENESS IN PATIENTS WITH DE NOVO AND RESTENOTIC LESIONS IN THE SFA AND/OR POPLITEAL ARTERIES. CLINICAL FOLLOW-UP FOR ALL SUBJECTS WILL BE PERFORMED AT HOSPITAL DISCHARGE, 30 DAYS, 12,24 AND 36-MONTHS POST-PROCEDURE. IMAGING DATA, THAT IS, FOLLOW-UP ANGIOGRAPHIC, X-RAY AND COLOR DUPLEX ULTRASOUND ASSESSMENTS, WHEN PERFORMED, WILL BE REVIEWED BY A CORE LABORATORY. THE PRIMARY EFFECTIVENESS ENDPOINT FOR THE STUDY WILL BE DEFINED AS THE FREEDOM FROM PROCEDURAL DEVICE MALFUNCTION. THE PRIMARY SAFETY ENDPOINT FOR THE STUDY WILL BE DEFINED AS THE FREEDOM FROM DEATH AT 12-MONTHS POST-PROCEDURE. IN ADDITION TO THIS INFORMATION, THE REPORTS FOR THIS STUDY WILL ALSO INCLUDE ENROLLMENT INFORMATION (I.E., NUMBER OF PATIENTS ENROLLED PER SITE); A LINE LISTING SUMMARIZING INFORMATION CAPTURED IN THE CASE REPORT FORMS; AND DATA SUMMARIES, ANALYSES, AND INTERPRETATION FROM THE ENROLLED PATIENTS.   CONTINUIM 02/13/2009 Adult: >21 Progress Adequate RESILIENT 02/13/2009 Adult: >21 Progress Adequate

CONTINUIM Schedule

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