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.
The proportion of subjects in NYHA class I or II at 5 years: all Biocor
valve positions - 91.5% (97/106), Aortic position - 93.1% (41/44), Aortic Supra position - 90.9% (40/44) and Mitral position- 88.9% (16/18)
Study Strengths and Weaknesses
The study achieved a high follow-up rate of 94.7% at 5-year post implant, and an
overall follow-up of
959.4 late patient years greater than the expected 800 late patient years. At least 100 patients were
followed out to 5 years as required per protocol.
This was a single arm study without a comparator. Thus, the study result was not evaluated by a formal statistical test.
Recommendations for Labeling Changes
Labeling change is recommended to reflect the long term data from the post-approval study. The
labeling change should include a new section on the label showing a summary of the post-approval study methods (including study objectives, design, population, number of enrolled sites/subjects, key endpoints, follow ?up visits etc.), final results and study strengths and limitations of the PAS.