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Problematic Medical Devices Force FDA To Change Rules

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The booming market of medical devices has forced the U.S. Food and Drug Authority to review its own approval process.

FDA Overhauls Medical Device Approval Process

This week, public health officials published the De Novo Classification Proposed Rule, which would create a fast and efficient classification process for new technology. This was a response to an investigation indicating faulty but approved devices have caused injuries to consumers.

The changes that will be implemented will urge manufacturers to base new medical devices on technologies that are 10 years old or newer. Since 1976, the FDA has been clearing new medical devices only if they can prove that their effects are equivalent to its 510(k) counterpart — devices that have been tested and proven effective but were developed decades ago. Almost 20 percent of the products that were cleared by the FDA was based on devices that are older than 10 years.

With the new system, the FDA hopes to retire those older base products that are often no longer available in the market. The federal agency will also make it easier for manufacturers to establish new base products that will be safe and effective.

Commissioner Scott Gottlieb said that the FDA has been planning to make changes to its approval system way before investigative reports from multiple publications came out.

"What we want to do is constantly push the market toward incorporating better technology and better capabilities by advancing the predicates and always looking forward so the ... predicates the device companies are using as the basis of their approvals are constantly incorporating newer and better technology to make the devices better and safer," he explained to CNBC.

FDA-Approved Devices Hurting Consumers

A report by the Associated Press published on Nov. 27 probed a spinal-cord stimulator that has been linked to more than 80,000 injuries in the United States since 2008. The report tracked FDA data of patients who used the medical device and were either shocked, burned, or suffered a spinal-cord nerve damage. More than 500 reports include death, but not enough details were provided.

The federal agency tracks about 4,000 medical devices. Metal hip replacements and insulin pumps have also been linked to patient injuries.

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