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.
Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v
Silver Spring, MD
20993-0002
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.
Followup Visits and Length of Followup
N/A, There is no follow-up of focus group participants.
Final Study Results
Actual Number of Patients Enrolled
There were 29 augmentation participants and 23 reconstruction participants.
Actual Number of Sites Enrolled
N/A
Patient Followup Rate
N/A, There was no follow-up of focus group participants.
Final Safety Findings
N/A, There are no safety findings.
Study Strengths and 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.
