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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-Registry Study
Study Status Progress Inadequate
Study Progress Reason Site enrollment milestones not met
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description All-comers registry study
Study Population Description Patients with cervical cancer treated with BSD-2000. Patients who

have had or not had prior irradiation   show the rest ...
Sample Size No specified sample size or number of clinical sites. Data will be

collected on all patients   show the rest ...
Data Collection Primary endpoint:

-Rate of complete response (CR), defined as the disappearance of all viable tumor in   show the rest ...
Followup Visits and Length of Followup Up to 3 years.

Follow-up examinations will be performed at 3, 12, 18, 24 and 36   show the rest ...

OSB Lead-Registry Study Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
annual report 11/19/2013 11/19/2013 On Time
six month report 05/13/2014 05/14/2014 Overdue/Received
one year report 11/13/2014 11/26/2014 Overdue/Received
18 month report 06/13/2015 11/23/2015 Overdue/Received
two year report 11/13/2015   Overdue

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