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U.S. Department of Health and Human Services

Post-Approval Studies

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Post-Approval Studies

  • 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.

Links

Contact Information

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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General
Application Number P040052
Most Recent Protocol Version Approved 10/18/2007
Study Name SURE Study
Study Status Completed
General Study Protocol Parameters
Study Design Cross-Sectional Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The study was designed to have the 295 pairs (590 individual slides) of slides. Each   show the rest ...
Study Population Description Study Poluation: Women 18 years or older who receive cervical cancer screening. Indication: The MonoGen   show the rest ...
Sample Size 295 patients, 85 sites
Data Collection The goal of the study was to evaluate cytology slides for adequacy determination and the   show the rest ...
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   show the rest ...
Study Strengths and Weaknesses A weakness of the study was that each slide evaluated by only one pathologist and   show the rest ...
Recommendations for Labeling Changes The sponsor submitted a labeling change. The revisions submitted by the sponsor were not approved.


SURE Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
18 month report SURE 09/04/2007 09/04/2007 On Time
Final Report for SURE Study 09/04/2007 09/04/2007 On Time

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