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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.


Contact Information

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

Phone: (301) 796-6134
Fax: (301) 847-8140

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Application Number H090002
Current Protocol Accepted 11/13/2013
Study Name OSB Lead-Deep Hyperthermia and Radiation
Study Status Revised/Replaced Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) Yes
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Interventional; Open Label; Uncontrolled; Registry
Study Population Description Females that are 21 and older that are ineligible to undergo chemotherapy.
Sample Size All patients treated with the BSD-2000 over the 3-year enrollment period
Data Collection 1st endpoint ¿ complete tumor response (CR); 2nd endpoints ¿ safety (i.e. adverse events and   show the rest ...
Followup Visits and Length of Followup Up to 36 months after enrollment and expect follow-up completion to be done 72 months   show the rest ...

OSB Lead-Deep Hyperthermia and Radiation Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report 05/18/2012 05/15/2012 On Time
18 month report 05/18/2013 05/15/2013 On Time

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