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.
Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v
Silver Spring, MD
20993-0002
This is a follow-up of the pre-market study patients.
Study Population Description
Study Population: All patients remaining at approval of device. Indication: For reconstruction of the temporomandibularjoint.
Sample Size
150 patients, 8 sites
Data Collection
The primary endpoints include quality of life, jaw pain, jaw function and, maximum interincisal opening,
patient satisfaction and implant removal.
Followup Visits and Length of Followup
Patients will be followed for 3-years post implant. The follow-up schedule was not noted.
Final Study Results
Actual Number of Patients Enrolled
288
Actual Number of Sites Enrolled
Not stated
Patient Followup Rate
91%
Final Safety Findings
Of the enrolled patients, 98.4% of known patients retained the implant at three years. However,
there are 32 patients lost to follow-up and 12 with no response. If all patients lost to follow-up or with no response were included as failures at 3 years, survival of device implant would remain over 90%, indicating reasonable assurance of safety.
Study Strengths and Weaknesses
The strength of the study is that there is adequate follow-up. The weaknesses of the
study is that there were no hypothesis or sample size calculations.
Recommendations for Labeling Changes
There were no recomendations were made for labeling changes.
