Galveston medical device attorneys respond: When the FDA first received its authority to approve medical devices back in 1976, it said that medical devices already on the market could stay there without additional testing. These devices’ approvals essentially got grandfathered in.

For new medical devices introduced to the market since that time, more than 90% benefit from exceptions to the rigorous testing and approval process. The exceptions reside in section 510(k) of the FDA’s rules and offer manufacturers an easy, expedited approval process.

One of the primary exceptions used by medical device makers is one that allows a product that’s “substantially equivalent” to an existing product to hit the market with no additional testing. It may be that the old product to which the new product is substantially equivalent never received testing. The new one won’t require testing either.

The new medical device products, if dangerous, can only be weeded out later. After data has accumulated and become widely accepted as showing injuries and/or deaths from the products, then the FDA can recall the products that should have been researched and tested in the first place before ever being offered to patients.

The FDA testing and approval process subjects less than 10% of new medical devices to testing in patient studies before approval. Devices requiring testing include those such as pacemakers that pose imminent dangers to health and life if they underperform or fail. Other implanted medical devices like all metal hip replacement joints, which become part of your body, require no testing before arriving on the market.

When these implanted medical devices fail or reveal a serious flaw, they might not end your life at once like a failed pacemaker might. But they might cause you prolonged pain and dangerous complications. Medical bodies, citizens’ organizations, and others are beginning to recognize the weaknesses of the FDA testing and approval process and call for reforms. Concurrently, medical device manufacturers are calling for a faster and more streamlined FDA approval process to get their devices quickly into the highly competitive medical marketplace.

If a defective medical device has injured you and you have questions about how you can get compensation for your undeserved pain and injury, contact our skilled Galveston medical device attorneys at Denena & Points. We offer a free and confidential case evaluation to discuss your injury and answer your urgent questions. Call 877-307-9500 or use our web contact form today.