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.
Transit. Adolescent B (as adults) : 18-21 yrs,
Final Study Results
Actual Number of Patients Enrolled
A total of 45 subjects. (18 in the augmentation group, 17 in the reconstruction group
and 10 in the revision group)
Actual Number of Sites Enrolled
Patient Followup Rate
Final Safety Findings
In general, both indication specific brochures were well received. Overall, participants found the booklet easy to
comprehend, saying it was organized in a logical way and written in language that was appropriate for the lay reader. As with the indication-specific brochure, the mini brochure was generally rated highly by focus group participants. The reconstruction groups rated it slightly lower than the augmentation groups, because they felt that it was aimed more to augmentation patients
Study Strengths and Weaknesses
The focus group study is useful in exploring ideas and concepts through group interaction. However,
the analysis is qualitative, it is difficult to generalize results from a small number of participants, and data analysis can be time consuming due to the open-ended nature of questions proposed for the focus group discussion
Recommendations for Labeling Changes
No labeling change is recommended. The Focus Group Study was conducted to evaluate Patient Educational
Brochures. No safety/effectiveness data of the sponsor-s approved device were collected in the study. Allergan is considering the aesthetic comments related to photos, colors and font sizes for future labeling updates.