|
In the United States, the Food and
Drug Administration's Center for Devices and Radiological
Health has regulatory authority over the SMSI®
glucose monitor. As there is no similar approved medical
device, a Pre-Market Approval (PMA) application process
is underway.
The PMA application must contain
valid scientific evidence to provide reasonable assurance
of the safety and effectiveness of the device. This
evidence includes the results of years of clinical trials,
animal studies, and all relevant laboratory tests. The
PMA approval route can require two phases of clinical
testing, the pilot and pivotal phases.
An FDA review of a PMA generally
takes one to two years from the date the PMA application
is filed. This approval process is sometimes expedited
through a modular PMA review, in which the Quality Systems,
Manufacturing, Pre-clinical, and other modules of the
PMA filing can be submitted and reviewed by the FDA
prior to completion of the clinical testing module.
SMSI is currently performing pre-clinical
studies on the device.
Major Steps in the PMA approval process:
| Feasibility
studies |
|
| Pre-clinical studies |
UNDERWAY
|
| Pilot clinical studies |
|
| Pivotal clinical studies |
|
| PMA application |
|
|
FDA review
- Manufacturing Inspections
- Possible FDA Advisory Panel
|
|
| Product Launch (if approved) |
|
| Post-approval monitoring and clinical
studies |
|
Copyright © 2008 Sensors for Medicine and Science, Inc.®
All rights reserved. Date of last update: 4/8/08.
Refer to Terms and Conditions
for use of this Web site.
|
