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.
(Other key safety endpoints are subsumed in primary effectiveness endpoint
Final Effectiveness Findings
CDTLR at 3 years: 30%
Major amputation rate at 3 years: 0.8% Death rate at 30
Study Strengths and Weaknesses
The main study limitations derive from the fact that the study population consisted of subjects
from the premarket cohort. Premarket studies are typically characterized by providers who are exceptionally skilled, and are therefore likely to provide relatively good results. However, this study is just one component of a two-component PAS requirement. The other component, which is not yet completed, utilizes newly enrolled patients obtained from different sites, which are more likely to be typical of the general population of providers.