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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 P050050
Most Recent Protocol Version Approved 11/23/2010
Study Name Actual Conditions of Use Study
Study Status Progress Adequate
General Study Protocol Parameters
Study Design Other Study Design
Study involve follow-up of premarket cohort (Y/N) No
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Prospective, multi-center, single-arm study
Study Population Description Consecutive subjects meeting all inclusion criteria and none of the exclusion criteria and giving informed   show the rest ...
Sample Size 98
Data Collection Overall patient success is defined as: a. 40 point improvement in total Buechel-Pappas Scale score,   show the rest ...
Followup Visits and Length of Followup Patients in the Actual Conditions of Use study will be evaluated at baseline, 6 weeks,   show the rest ...


Actual Conditions of Use Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
6 month report 03/29/2010 03/29/2010 On Time
1 year report 05/27/2010 05/28/2010 Overdue/Received
18 month report 11/25/2010 11/18/2010 On Time
2 year report 05/27/2011 05/27/2011 On Time
3 year report 05/26/2012 05/25/2012 On Time
4 year report 05/27/2013 05/28/2013 Overdue/Received
5 year report 06/26/2014 06/27/2014 Overdue/Received

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