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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 H100006
Current Protocol Accepted 09/28/2011
Study Name NeuRx DPS
Study Status Progress Inadequate
Study Progress Reason Subject 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 New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective, non-randomized, open-label, interventional study.
Study Population Description This study will enroll ALS patients who meet the HDE-approved device indications for use and   show the rest ...
Sample Size Based on practical considerations in this small subpopulation of patients with ALS who meet the   show the rest ...
Data Collection This study will examine the following safety and probable benefit outcomes of interest:

Safety Outcome Measure:   show the rest ...
Followup Visits and Length of Followup 9 months

0 ¿ 1 month, 1- 3 months, and every 3 months thereafter until post-implant   show the rest ...


NeuRx DPS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
six month report 03/28/2012 03/28/2012 On Time
one year report 09/27/2012 09/27/2012 On Time
two year report 09/27/2013 09/27/2013 On Time
three year report 09/27/2014 09/26/2014 On Time
four year report 09/27/2015    
five year report 09/26/2016    
Final Report 12/26/2016    

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