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FDA joins medical device association with key role

Posted on in FDA

On December 3, 2012 the U.S. Food and Drug Administration announced that the agency has become a part of a nonprofit group that consists of representatives from across the medical device industry, nonprofit associations, and the government. The FDA chose to become a part of the organization to fulfill its aspiration to further patient access to new and safe medical devices.

The new Medical Devices Innovation Consortium, ideally, will help to improve the government's methodologies with which they assess the safety, quality, effectiveness, and performance of new medical devices. With these new changes, the panel could “not only aim to improve how products are developed and evaluated, but also could reduce the cost and time it takes for a promising device to come to market,” according to an FDA statement.

An example of an innovation that the nonprofit consortium may attempt is a computer model that can “test an implant on a virtual patient before a manufacturer spends the time and budget to study that product in a clinical trial.”

Another advancement from this new group is the member organizations will pool their resources and fund projects together to help simplify the process that the products take to be designed and sent to market. The FDA's new relationship with the consortium could, potentially, ensure that the industry does not regulate itself and bring to market medical devices that are very unlikely to be efficient, as well.

Although this new collaboration in the medical device industry will bring about great changes and efficiency to all involved, most importantly to the patients, there will still be mistakes. If you or someone that you know has had troubles with a defective medical device, contact Newland & Newland attorneys to help fight for you. These experiences defective medical device attorneys will defend you.

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