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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 P030053
Current Protocol Accepted 11/17/2006
Study Name Informed Decision Process
Study Status Completed
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 No Control
Analysis Type Descriptive
Study Population Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The Informed Decision Process study is a random survey of physicians on an annual basis   show the rest ...
Study Population Description Each year, a random selection of 50 physicians are targeted for a survey to determine   show the rest ...
Sample Size A total of 50 physicians surveyed each year
Data Collection Survey is administered to 50 physicians and asks questions on the level of understanding a   show the rest ...
Followup Visits and Length of Followup There are no follow up visits in this study
Final Study Results
Actual Number of Patients Enrolled The Informed Decision Process consisted of yearly surveys. Each year a different sample was selected   show the rest ...
Actual Number of Sites Enrolled N/A
Patient Followup Rate N/A
Final Safety Findings N/A
Final Effectiveness Findings The majority of respondents (94.2%) said the Informed Decision Brochure was of value in helping   show the rest ...
Study Strengths and Weaknesses The sample of physicians was chosen randomly, which is a strength of the study.



However, the   show the rest ...
Recommendations for Labeling Changes Mentor has no current plans to change the Informed Decision Process based on the survey   show the rest ...


Informed Decision Process Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
2 year report 11/16/2008 11/12/2008 On Time
3 year report 11/16/2009 11/16/2009 On Time
4 year report 11/16/2010 11/05/2010 On Time
5 year report 11/16/2011 11/07/2011 On Time

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