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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

Show All Studies
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General
Application Number P000008 S017
Current Protocol Accepted 09/24/2014
Study Name BOLD-001
Study Status Study Pending
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 Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description New enrollment study designed to evaluate the safety and effectiveness of

Lap-Band. Prospective single-arm cohort.

  show the rest ...
Study Population Description Patients with BMI >=30 kg/m2 and <40 kg/m2 and 1 or more obesity-

related comorbidities. There   show the rest ...
Sample Size 325 subjects will be enrolled across 20 U.S. sites. Assuming 20% attrition, a sample size   show the rest ...
Data Collection Primary safety endpoint: 5-year explant rate; Secondary effectiveness

endpoints: 5-year responder rate (where response is defined   show the rest ...
Followup Visits and Length of Followup 10 Years - In-office visits before and after surgery, at 1, 2, 3, and 6   show the rest ...


BOLD-001 Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
six month report 08/17/2011 11/25/2011 Overdue/Received
one year report 02/16/2012 02/15/2012 On Time
18 month report 08/16/2012 08/17/2012 Overdue/Received
two year report 02/15/2013 02/13/2013 On Time
Interim Progress Report 08/14/2013 08/14/2013 On Time
three year report 02/15/2014 03/13/2014 Overdue/Received
report 03/24/2015    
Report 09/24/2015    

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