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BREAKING: FDA Overhauls Medical Device Approval Protocol

On Monday, November 26th, the Food and Drug Administration announced they would be overhauling the most common process of medical device approval. In 2017, the FDA cleared 3,173 devices under the 510(K) process, or 82 percent of the total devices cleared or approved, Gottlieb and Shuren said in their statement to the press. “Data shows that nearly 20 percent of current 510(k)s are cleared based on a predicate that’s more than 10 years old.” Now the FDA wants to “retire outdated predicates” (older products), some of which are no longer on the market. In modernizing this product, the FDA wants to encourage companies to base their new products on devices that are no older than 10 years.

In a press conference on Monday, FDA Commissioner Scott Gottlieb said, “We believe that where appropriate, new medical devices that come to market under the 510(k) pathway should either account for advances in technology or demonstrate that they meet more modern safety and performance criteria.” CNBC pointed out that the press release was conveniently called after several news outlets published scathing investigations “into medical device failures and how the FDA’s accelerated review process may have missed problems and put consumers at risk.”

Already this new initiative is receiving pushback from medical device manufacturers. AdvaMed CEO Scott Whitaker said in a statement that “the proposed 10-year cut off criteria could prove arbitrary as older predicates can offer extensive data about their performance, which helps sponsors introduce newer, safer devices”. In the coming months. the FDA is considering publicizing cleared devices and manufacturers that are based on technology older than 10 years.

The History

In 1976, the FDA began regulating approvals for the manufacture of medical devices. Any medical device on the market before 1976 was grandfathered in and went untested by the administration. There are two device approval processes, Premarket Approval (PMA) and Premarket Notification (PMN), called the 510(K) process. According to the FDA’s website “PMA is the most stringent type of device marketing application required by FDA.”  To be approved under PMA, the manufacturer must test the medical device on humans, compile the scientific data, and present their findings to the FDA scientists who will decide if the device is safe and effective.

Even though new devices are expected to go through premarket approval, some medical companies argue that, with the rate of innovation, “it’s too expensive to send each device through massive amounts of clinical testing.” When manufacturers apply under the 510(K) process, all they need to demonstrate is that their device is “substantially equivalent” to a device already on the market. Even if the prior device they base theirs off has been recalled, it will not affect the approval of the new device.

Contact an Attorney

If you or someone you know has suffered harm in connection with a defective medical device, please call Schneider Hammers and speak with an Atlanta personal injury lawyer today. Because there is only a two-year statute of limitations in Georgia, time is of the essence in getting the help you need. Our seasoned legal team may be able to help you recover compensation for the losses you have sustained through the use of the device, including pain and suffering, past and future medical bills, lost wages, and more. We have handled countless dangerous medical device cases in our years of experience and are not afraid to take your case to court to obtain the best results possible.