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 post-approval study is a clinical study to estimate the positive predictive concordance between the
breast lymph node assay and histology as routinely practiced i.e., routine hematoxylene and eosin histology of sentinel lymph node(s), and when available, routine histology of non-sentinel axillary lymph nodes. The positive predictive concordance value is defined as the proportion of breast lymph node assay positive subjects with histologically detectable breast cancer metastases.
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.
1,000 female or male patients to include a minimum of 246 breast lymph node positive
patients, 4 sites
The primary endpoint is the efficacy endpoint as measured as a metric that uses the
less thorough reference. The metric is the positive predictive concordance between the breast lymph node assay and histology as routinely practiced i.e., routine hematoxylene and eosin, histology of sentinel lymph node(s), and when available, routine histology of non-sentinel axillary lymph nodes.