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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 P130008
Current Protocol Accepted 09/19/2014
Study Name New Enrollment Study
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 Adult: >21
Detailed Study Protocol Parameters
Study Design Description To collect additional long term safety, training performance and effectiveness data in a postmarket setting.   show the rest ...
Study Population Description Patients will be screened for inclusion/exclusion criteria.

Eligible subjects will be implanted and followed for five   show the rest ...
Sample Size A total of 127 subjects will be implanted at a minimum of 10 and a   show the rest ...
Data Collection Safety Endpoints

Evaluate long-term device-related serious adverse events.

Evaluate therapy-specific adverse events (stimulation discomfort, tongue abrasions weakness   show the rest ...
Followup Visits and Length of Followup 5 years post-implant


New Enrollment Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
six month report 10/29/2014    
one year report 04/30/2015    
18 month report 10/29/2015    
two year report 04/29/2016    
three year report 04/29/2017    
four year report 04/29/2018    
five year report 04/29/2019    
six year report 04/28/2020    
seven year report 04/28/2021    
Final Report 09/28/2021    

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