FDA Increases Safety Oversight for Medical Devices

January 2006

After critics complained the Food and Drug Administration (FDA) wasn’t aggressively monitoring Guidant heart device malfunctions, the agency will step up their safety guidelines.

Under new guidelines, the FDA will require annual safety reports from medical device makers to be more specific and more accessible to the public. In the past, the FDA did not always release safety data from these annual filings because they felt it to be confidential. Along with the revised guidelines, the FDA will also change the way they receive their safety information, because it is often incomplete and lacking in uniformity. The information it does receive is not always shared throughout the FDA.

The FDA task force formed specifically for reviewing and improving the safety of defibrillators and pacemakers is expected to release the new rules this spring.

For more information about defective medical devices, visit our Defective Medical Devices Legal Center.

Injured by a Defective Product? Contact Us Now For a Free Evaluation of Your Legal Case.

Call us toll-free at 1-866-943-3427 or get online legal help, and we'll give you a free evaluation of your claim.