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 was designed to have the 295 pairs (590 individual slides) of slides. Each
subject was represented by a pair of slides: a Pap Smear slide and a MonoPrep Pap test slide. The MonoPrep Pap test slide was prepared from the Pap Smear slide residuum. Both sets of slides were assessed for specimen adequacy by the participating laboratories, and the slides were labeled as 'satisfactory' or 'unsatisfactory' accordingly. The adequacy determination (satisfactory/unsatisfactory status) and the underlying reason for an unsatisfactory status according to the TBS2001 criteria. For slides with adequacy determination of satisfactory, a diagnosis was assigned to the slide according to the TBS2001 criteria.
Study Population Description
Study Poluation: Women 18 years or older who receive cervical cancer screening. Indication: The MonoGen
Pap Test 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
295 patients, 85 sites
Data Collection
The goal of the study was to evaluate cytology slides for adequacy determination and the
underlying reason for unsatisfactory status. Data collection consisted of obtaining cervical cytology specimens.
Followup Visits and Length of Followup
Follow-up was not required for this study.
Final Study Results
Actual Number of Patients Enrolled
295
Actual Number of Sites Enrolled
N/A
Patient Followup Rate
Follow-up was not required for this study.
Final Safety Findings
The performance of MonoGen Pap Test and Pap Smear methods with regard to "miscall of
unsatisfactory slides" are the same.
Study Strengths and Weaknesses
A weakness of the study was that each slide evaluated by only one pathologist and
not a panel of pathologists.
Recommendations for Labeling Changes
The sponsor submitted a labeling change. The revisions submitted by the sponsor were not approved.
