FDA to Overhaul Approval Process that Puts Some at Risk

According to a press release on November 26, Food and Drug Administration officials said the agency would begin to overhaul a decades-old system used by medical device manufacturers to get their products on the market. The system is being revamped after failing to detect problems in certain medical devices, which have caused injuries to consumers in some cases.

The FDA’s pledge came one day after the publication of a global investigation into medical device safety by more than 50 media organizations. The probe, led by the International Consortium of Investigative Journalists, analyzed more than 8 million device-related health records, including death and injury reports and recalls. The report found faulty spinal-cord stimulators have accounted for more than 80,000 injuries since 2008, and metal-hip replacements and insulin pumps had even more injury reports.

Most of these faulty devices uncovered in the report were spinal cord simulators that had been approved by the FDA with little clinical testing. According to the consortium’s report, the FDA’s own data showed spinal-cord stimulators have a disproportionately higher number of injuries compared to hip implants, which are far more plentiful.

Many of these device regulatory inconsistencies and errors were addressed in the 2017 book, The Danger Within Us: America’s Untested, Unregulated Medical Device Industry and One Man’s Battle to Survive It, by medical investigative journalist and physician, Jeanne Lenzer.

The FDA overhaul will base approvals of new medical technologies on clinical testing, rather than a system based on a device’s similarities to older technologies. Hearing aids were not mentioned in the report. According to a Wall Street Journal article on the announcement, the FDA responded to the matter last week, saying it would need to create “a more robust medical device safety net for patients through better data.” The agency added, “Unfortunately, the FDA cannot always know the full extent of the benefits and risks of a device before it reaches the market.”

“What we want to do is constantly push the market toward incorporating better technology and better capabilities,” said FDA Commissioner Scott Gottlieb, a President Trump appointee, in an interview with CNBC. He emphasized the need for “constantly incorporating newer and better technology to make the devices better and safer.”

The FDA’s overhaul of the 510(k) system is meant to prompt manufacturers to base new products on technologies that are 10 years old or less. Almost 20% of the products currently cleared by the system were based on devices older than 10 years.

For consumer safety, the FDA is considering whether to publicize manufacturers and their devices that are based on older products.


Source: FDA

1 Comment

  1. FDA should know that technology is progressive, and new development must necessarily follow the development of new scientific findings. This takes time. Encouraging the acceleration of tech concepts will only put bad technology into the market, and the victims will be the hearing impaired, while the manufacturers will pocket the money.
    Not a good idea. FDA will be wise to stop interfering with this industry, and stop regulating it.

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