To understand the impact of this proposed change, 3,173 devices earned FDA approval in 2017 via the process – 82 percent of all devices approved that year. Of these, almost 20 percent used predicates over a decade old, the FDA noted in its statement.

The FDA is considering this new approach because devices are growing in complexity. “They often involve different technological features from the predicates on which they’re based. Newer devices are more often interconnected and interoperable, increasing cybersecurity threats. Miniaturization of device components has allowed devices to become smaller and more portable. Devices more frequently use automation and robotics, and advanced materials, changing the way healthcare providers and patients interact with them,” according to the agency.

Calling this a “market-based approach” the FDA stressed that it believes “it will promote the right kind of innovation for patients. Innovation that reflects the most modern principles.”

Steps the agency is planning include developing “proposals to potentially sunset certain older predicates and promote the use of more modern predicates,” noting that it will “consider whether this approach should become a requirement” going forward and that it may ask for “additional guidance from Congress.”

Modern devices must face a host of new concerns in the modern healthcare environment, not the least of which involves cybersecurity. In October, to address these concerns, the FDA and DHS formed a security coordinating framework to fight hacking in the medical arena.

“As innovation in medical devices advances and more devices are connected to hospital networks or to other devices, ensuring that devices are adequately protected against cyber intrusions is paramount to protecting patients. The FDA has been proactive in developing a robust program to address medical device cybersecurity concerns,” said Gottlieb at the time.

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