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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Informed Decision Process

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Study Status Completed
Application Number P030053 / PAS003
Date Current Protocol Accepted 11/17/2006
Study Name Informed Decision Process
General Study Protocol Parameters
Study Design Other Study Design
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 to determine the success of the informed decision process provided to woman who is seeking breast implants surgery
Study Population Description Each year, a random selection of 50 physicians are targeted for a survey to determine the success of the patient informed consent process.
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 patient has after consulting the Allergan patient planner.
Follow-up Visits and Length of Follow-up There are no follow up visits in this study
Interim or Final Data Summary
Interim Safety Information There is no interim device safety Information from this study
Actual Number of Patients Enrolled The Informed Decision Process consisted of yearly surveys. Each year a different sample was selected for the survey. These are the results for 2011 annual report.

54 surveys were returned. Per the condition of approval, the sponsor did administer the survey to a random selection of 50 physicians.
Actual Number of Sites Enrolled N/A
Patient Follow-up Rate N/A
Final Safety Findings N/A
Final Effect Findings The majority of respondents (94.2%) said the Informed Decision Brochure was of value in helping patients to understand the risks and benefits of implant surgery.
Study Strengths & Weaknesses The sample of physicians was chosen randomly, which is a strength of the study.

However, the observational, cross-sectional design of the study does not allow for any hypothesis testing. The results are descriptional only.
Recommendations for Labeling Changes Mentor has no current plans to change the Informed Decision Process based on the survey results. 

Informed Decision Process Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's 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

Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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