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
This is a prospective, single arm, multi-center study with consecutive enrollment.
The null hypothesis for
this study states that subjects implanted with the MedStream system will have a MedStream system-related AE rate that is greater than or equal to an Objective Performance Criterion (OPC).
Study Population Description
The study population included patients presenting for de novo implant or replacement of an implantable
programmable infusion pump for intrathecal therapy.
Sample Size
Subjects will be enrolled in the study to account for loss to follow-up and for
ineligibility to achieve evaluable subjects. The study will be conducted at a minimum and a maximum number of centers in the U.S. with prior IRB approval for this study.
Data Collection
The primary endpoint is based on Clinical Events Committee determination of relationship.
Followup Visits and Length of Followup
All subjects are to be followed for a few months and are required to have
a minimum of office or hospital-based visits every few months as long as he/she is enrolled in this study. These visits will be documented in the study records, and data will be collected on the Subject's current intrathecal drug therapy. Follow-up visits will be scheduled as deemed necessary by the treating Clinician.
