FDA Cuts Deal with Device Makers Image

FDA Cuts Deal with Device Makers

August 02, 2017 | Finz & Finz, P.C.

Recalls of medical devices have become frightfully common over the last ten years.  Rather than being absolutely certain of the safety of a product before it’s released, more and more manufacturers have taken to putting their product on the market and letting patients learn for themselves how dangerous the devices are.

The FDA (Food & Drug Administration) is the regulatory apparatus in charge of making sure that dangerous products don’t make it to market, and that if they do, they are pulled from the market as quickly as possible.  The FDA requires any new product to go through certification, where the developer must demonstrate the safety and efficacy of the product.

Despite this necessity, large amounts of patently unsafe products have made it to market over recent years.  Whether or not this is due to insufficient regulatory requirements or not is difficult to say.  Most of the testing done to determine product safety is funded or done by the manufacturer, and the manufacturer has a vested interest in getting their product on the market regardless of whether it is safe.  Products that never make it to market never make any money.

Patients themselves have borne the brunt of this danger, and now the number of patients put at risk by a certain device is set to increase.  The FDA has made a deal with medical device manufacturers, centered on lengthening reporting requirements from 30 to 90 days in case of medical device malfunction.  Though the stricter five day requirement would remain in place for particularly dangerous defects, it is difficult to know how often the FDA will enforce the five day provision versus the 90 day one.

Ninety days is a long time for a dangerous product to remain on the market.  Erring on the side of caution and requiring immediate notification should drastically limit the fallout of an unsafe product making it through certification.  If you or someone you love has been injured due to a defective medical device, knowing these products can stay available sixty days longer must be horrifying.  Please, retain an experienced attorney to help you make your case against the manufacturer.

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