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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 12/18/2007
Study Name CHOICE Study
Study Status Other
Study Progress Reason Device not marketed
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 Historical 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 consists of consecutive patients for whom a MonoGen Pap Test is performed at   show the rest ...
Study Population Description Study Population: Patients 18 years or older, with a Pap test and a minimum of   show the rest ...
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   show the rest ...
Followup Visits and Length of Followup Follow-up was not required for this study.


CHOICE Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
6 month progress report - meeting request 08/03/2006 08/03/2006 On Time
1 year status report 03/03/2007 03/02/2007 On Time
18 month report CHOICE 09/04/2007 09/04/2007 On Time
2 year report CHOICE 03/02/2008 03/03/2008 Overdue/Received
30 month report CHOICE 08/31/2008 09/02/2008 Overdue/Received

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