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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 P030025 S028
Current Protocol Accepted 09/24/2008
Study Name Fatigue/Matter Testing
Study Status Completed
General Study Protocol Parameters
Study Design Bench/Lab 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 Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a simulated use particulates testing, 10-year equivalent pulsatile particulates on a curve testing,   show the rest ...
Study Population Description N/A
Sample Size N/A
Data Collection This is a simulated use particulates testing, 10-year equivalent pulsatile particulates on a curve testing,   show the rest ...
Followup Visits and Length of Followup N/A
Final Study Results
Actual Number of Patients Enrolled NA
Actual Number of Sites Enrolled NA
Patient Followup Rate NA
Final Safety Findings NA
Final Effectiveness Findings NA
Study Strengths and Weaknesses NA
Recommendations for Labeling Changes None


Fatigue/Matter Testing Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
1 year report 09/24/2009 10/26/2009 Overdue/Received

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