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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 P080009
Current Protocol Accepted 11/03/2014
Study Name Open Label Post Market Registry in Clinical Practi
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 Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The study is an observational, single arm, non-randomized, non-blinded, multi-center, prospective, safety study of sedation   show the rest ...
Study Population Description Adult patients who satisfy the approved FDA labeling and are scheduled for non-emergent endoscopy procedures,   show the rest ...
Sample Size 7430 patients; including subject population (approximately 866) from CI-13-000X (PAS I). This sample size will   show the rest ...
Data Collection Primary: Total number of anesthesia professional rescue interventions <=1

Secondary: Subjects sedated requiring BMV and/or   show the rest ...
Followup Visits and Length of Followup Adult male and female subjects who satisfy the approved FDA labeling and are scheduled for   show the rest ...


Open Label Post Market Registry in Clinical Practi Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
six month report 11/01/2013 12/16/2013 Overdue/Received
one year report 05/03/2014 05/02/2014 On Time
18 month report 11/01/2014 10/30/2014 On Time
two year report 05/03/2015    
three year report 05/02/2016    
four year report 05/02/2017    
five year report 05/02/2018    

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