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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 P040028
Current Protocol Accepted 03/16/2006
Study Name LUMA
Study Status Terminated
Study Progress Reason Sponsor withdraws PMA
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Study Population Adolescent: 13-18 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study is a multi-center single-arm internally controlled trial that will enroll approximately 950 subjects   show the rest ...
Study Population Description Study population is as per device indication. This device is indicated for use as an   show the rest ...
Sample Size 800 evaluable women at 9 sites
Data Collection Each patient will be evaluated with colposcopy first and then with LUMA. Primary object is   show the rest ...
Followup Visits and Length of Followup There is no follow up in this study. Subject complete participation within 20 minutes.


LUMA Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
6 month report 09/14/2006 09/25/2006 Overdue/Received
1 year report 03/16/2007 03/21/2007 Overdue/Received
6 month report (Spectra) 09/15/2008 09/12/2008 On Time
1 year report (Spectra) 03/17/2009 03/03/2009 On Time
2 year report (Spectra) 06/21/2010 06/22/2010 Overdue/Received

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