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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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OSB Lead-Focus Group

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Study Status Completed
Application Number P020056 / PAS003
Date Current Protocol Accepted 11/17/2006
Study Name OSB Lead-Focus Group
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 There were 6 focus groups planned, each included 10 breast implant patients. In the moderator lead focus group the patients discuss the format and content of the approved labeling.
Study Population Description The study population is as per device indication. The device is indicated for breast augmentation for women at least 22 years old and for breast reconstruction for women of any age. The study population includes women age 18 years or older who had a breast implant or were considering getting breast implants.
Sample Size 10 patients in a each of 6 focus groups
Data Collection Recommendations on the patient planner and labeling were suggested by participants in the focus group.
Follow-up Visits and Length of Follow-up N/A, There is no follow-up of focus group participants.
Interim or Final Data Summary
Actual Number of Patients Enrolled There were 29 augmentation participants and 23 reconstruction participants.
Actual Number of Sites Enrolled N/A
Patient Follow-up Rate N/A, There was no follow-up of focus group participants.
Final Safety Findings N/A, There are no safety findings.
Study Strengths & Weaknesses The strength of the study was that the focus groups included augmentation and reconstruction patients. The weakness of the study was that the participants many not be representative of all breast implant patients.
Recommendations for Labeling Changes Changes were made to the Patient Planner based on the recommendatin of the focus groups. These changes included changing the order of text in the planner and making the planner available on-line.

OSB Lead-Focus Group Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
Focus Group Study Final Report 11/17/2007 11/16/2007 On Time

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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