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Will new FDA process let a defective medical device slip through?

Changes are afoot at the Food and Drug Administration. In a move designed to speed more medical devices through to consumers, some are worried that dangerous products will be let out on to the market and cause injuries. A defective medical device can leave lasting scars or even result in a wrongful death, so many advocates in California and across the United States are calling for stronger regulations, not weaker ones. 

The new FDA policies are expected to go into effect early next year. Some medical devices may be available on the market even as product makers still gather safety evidence. This may result in products being tested on the public before they have been thoroughly tested scientifically. A process called the 501(k) allows device designers to have their products approved if they show the item to be substantially similar to other devices currently being sold. 

Unfortunately, this substantially similar guideline has failed the public in the past. Sixty-one brands of pelvic mesh were ushered onto the market using the 501(k) process, and resulted in higher than average complications for those who used the material. No evidence of clinical trials was presented for the mesh products, nor was they required by the FDA using the current 501(k) process. 

Allowing a potentially defective medical device on the market too soon can have disastrous consequences for those seeking medical care. Hopefully, most of the problematic materials will be caught before causing harm to people. In California, a person who has been harmed by a defective product has the option to seek awards for damages in the courts. An experienced personal injury attorney can be a helpful guide during this process. 

Source: drugwatch.com, "New FDA Medical Device Approval Process Will "Lower the Bar"", Dec. 12, 2017

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