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 study consists of consecutive patients for whom a MonoGen Pap Test is performed at
the participating laboratories constitute the MonoGen Pap Test arm of this study. These patiens will be compared to historical Pap smear slides from the same laboratories.
Study Population Description
Study Population: Patients 18 years or older, with a Pap test and a minimum of
400 HSIL. There were also 360 patients who have an accompanying colposcopy/biopsy results. Indication: The MPPT is intended for use in collecting and preparing cervical-vaginal cytology specimens for Pap stain-based screening for cervical cancer, its precursor lesions, and other cytologic categories and conditions defined by the 2001 Bethesda System for Reporting Results of Cervical Cytology.
Sample Size
400 HSIL patients and 360 patients with an accompanying colposcopy/biopsy, 3 sites
Data Collection
Data will be collected on the MonoGen Pap test results for MPPT patients and Pap
smear results will be obtained from the control patients. The endpoint includes cervical cytology results from cervical-vaginal cytology specimens using both MPPT method for the prospective arm and PS method for the historical arm. For cases with cytologic diagnosis of HSIL+ from both MPPT and PS arms, comparative data from histological examination (colposcopy and, if appropriate, biopsy) will be collected.
