FDA proposes 510(k) process changes
December 03, 2018
by Thomas Dworetzky, Contributing Reporter
There could be changes coming to the 510(k) expedited approval process used by the Food and Drug Administration to OK medical devices.
This process lets device makers use the less demanding practice of comparing a new device to older ones on the market if they can show that it's “at least as safe and effective" as one that already was approved. It also means that the new devices may well be measured against very old technology – known as “predicate devices.”
The agency now wished to end the use of these present predicates, but also make it easier to introduce new ones, FDA Commissioner Scott Gottlieb and Center for Devices and Radiological Health Director Jeff Shuren said in a statement.
"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," Gottlieb said Monday in an interview with CNBC's Becky Quick.
Gottlieb, a Trump appointee, has spearheaded the drive to cut regulations in order to make it easier for industry to get devices to market, according to the news site, noting that “in modernizing the 510(k) approval process, the FDA wants to nudge companies to base new products on devices that are no older than 10 years old.” And in cases of “devices and manufacturers whose products are based on even older technology,” it added, the agency could publicize the fact that they were compared to much older tech.
“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,” said the FDA in a second related statement, adding that, “we want to make sure that new devices are evaluated against advances in technology that can improve patient safety and performance. In making these reviews, where appropriate, we want to rely on modern safety and performance criteria.”
AdvaMed took issue with the 10-year cutoff.
“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,” its CEO Scott Whitaker said in a statement.
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.
This process lets device makers use the less demanding practice of comparing a new device to older ones on the market if they can show that it's “at least as safe and effective" as one that already was approved. It also means that the new devices may well be measured against very old technology – known as “predicate devices.”
The agency now wished to end the use of these present predicates, but also make it easier to introduce new ones, FDA Commissioner Scott Gottlieb and Center for Devices and Radiological Health Director Jeff Shuren said in a statement.
"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," Gottlieb said Monday in an interview with CNBC's Becky Quick.
Gottlieb, a Trump appointee, has spearheaded the drive to cut regulations in order to make it easier for industry to get devices to market, according to the news site, noting that “in modernizing the 510(k) approval process, the FDA wants to nudge companies to base new products on devices that are no older than 10 years old.” And in cases of “devices and manufacturers whose products are based on even older technology,” it added, the agency could publicize the fact that they were compared to much older tech.
“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,” said the FDA in a second related statement, adding that, “we want to make sure that new devices are evaluated against advances in technology that can improve patient safety and performance. In making these reviews, where appropriate, we want to rely on modern safety and performance criteria.”
AdvaMed took issue with the 10-year cutoff.
“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,” its CEO Scott Whitaker said in a statement.
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.