New Safety Features for Medical Devices

November 2006

Attempting to improve their handling of medical device safety issues, the Food and Drug Administration (FDA) is revamping their procedures.

Under the new plan, the FDA hopes to reorganize their Center for Disease and Radiological Health to more easily share safety information. The FDA would like to also improve how information is received from multiple sources.

The FDA is considering expanding a pilot program that collects safety reports from hospitals. They would also like to use data from the Department of Veterans Affairs, the Department of Defense and Centers for Medicare and Medicaid services.

The agency is under more scrutiny since there were a number of recalls and safety warnings affecting more than 200,000 heart defibrillators and pace makers. In addition, the FDA would like all medical devices to have a unique number so that they can be easily tracked in a recall.

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