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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 P030050 S002
Most Recent Protocol Version Approved 09/09/2010
Study Name Pre Clinical PAS
Study Status Completed
General Study Protocol Parameters
Study Design Animal Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Detailed Study Protocol Parameters
Study Design Description This is an animal study designed to determine the potential visibility of device by various   show the rest ...
Study Population Description 8-9 weeks old male rats [Crl:CD (SD), Charles River, US Raleigh, NC USA]
Sample Size The study includes 10 rats.
Data Collection Bioimaging procedures will be taken on Day 91, approximately 24 hours after 2nd injection.All animals   show the rest ...
Followup Visits and Length of Followup The rats will be followed for approximately 91 days.
Final Study Results
Actual Number of Patients Enrolled 10 male rats
Actual Number of Sites Enrolled 1
Patient Followup Rate 100%
Final Safety Findings Not applicable
Final Effectiveness Findings Not applicable
Study Strengths and Weaknesses

Strengths: (1) Phantom studies were conducted for each imaging modality to estimate the possible visualization   show the rest ...
Recommendations for Labeling Changes The labeling will be changed to report the objectives, methods and results of the preclinical   show the rest ...


Pre Clinical PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
6 month status report 01/28/2010 01/28/2010 On Time
FINAL REPORT 08/05/2010 08/05/2010 On Time

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