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
The post-approval study is designed to address the following objectives: 1) to determine, under clinical
use conditions, the assay turn-around-time from the time of node removal to the report of the assay result to the surgeon, 2) to determine, under clinical use conditions, whether the assay result was or was not received in time to make an intra-operative decision, and 3) to collect data in relation to other surgical procedures during the sentinel lymph node dissection/breast surgery to determine if the assay turn arround time resulted in longer surgery time than would have occurred if the assay had not been used.
Study Population Description
Study Population: Breast cancer patients. Indication: The device is indicated as an in vitro diagnostic
test for the rapid detection of greater than 0.2 mm metastases in nodul tissue removed from the sentinel lymph nodes biopsies of breast cancer patients.
Sample Size
320 patients, 4 sites
Data Collection
Assay turn-around-time data was collected on each eligible patient from the time the sentinel lymph
node(s) were excised from the patient until the patient assay result was reported back to the surgeon. The relationship to other surgical procedures during the sentinel lymph node dissection/breast surgery will be collected to determine if the assay turn-around-time resulted in longer surgery time than would have occurred if the assay had not been used.
