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 is a prospective, cohort study. The study consists of women that are 30
years or older with a normal Pap test and Cervista HPV test at baseline. The enrolled subjects come back for their routine screening visits on an annual basis and have a Pap test at each follow-up visit.
Study Population Description
Study Population: Women 30 years or older who have a NILM cytology result at baseline.
Indication: 1) To screen patients with atypical squamous cells of undetermined significance cervical cytology results to determine the need for referral to colposcopy. 2) In women 30 years and older, the Cervista HPV HR test can be used with cervical cytology to adjunctively screen to assess the presence or absence of high-risk HPV types.
Sample Size
2000 patients, 26 sites
Data Collection
There are no safety endpoints, The effectiveness endpoints include cervical cytology, colposcopy/biopsy, and high risk
HPV test result.
Followup Visits and Length of Followup
The study required 3 years of follow-up. Follow-up inculdes annual visits.
