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 study is a prospective open-label study with no control group. The study was designed
to assess the development of keloid formation, hypertrophic scarring, and pigmentation changes.
Study Population Description
This device is indicated for subdermal implantation for the correction of moderate to severe facial
wrinkles and folds such as nasolabial folds. The study population includes patients 18 years or older with Fitzpatrick skin types IV-VI who receive Radiesse for treatment of nasolabial folds.
Sample Size
100 patients, 5 sites
Data Collection
There were no primary effectiveness endpoints defined. Adverse events were assessed at 3 month and
6 month office visits.
Followup Visits and Length of Followup
The study required 6 month follow-up. Evaluation was done at baseline, 3 months, and 6 months.
Final Study Results
Actual Number of Patients Enrolled
100 patients
Actual Number of Sites Enrolled
5 sites
Patient Followup Rate
98%
Final Safety Findings
There was one case of hyperpigmentation on the lip noted.
Study Strengths and Weaknesses
The weakness of the study was that there was no control group.
Recommendations for Labeling Changes
Update labeling to reflect the results of the PAS taking into account study limitations
