- FDA on Monday proposed boosting scrutiny of an often used regulatory pathway by limiting medical device maker reliance on 510(k) predicate devices older than 10 years to those that have been more recently approved. It also plans to release its proposed rule "clarifying procedures and requirements for submissions of De Novo requests" within a few weeks and finalize its Abbreviated 510(k) guidance in early 2019.
- The agency is also asking Congress for help: FDA says that it may need more authority to impose special controls more quickly, such as new labeling or sale restrictions, on a type of 510(k) device when safety concerns arise. The current rulemaking process to impose such controls on a case-by-case basis is too "lengthy and inefficient, making it challenging to implement necessary safety mitigations in a timely way," according to FDA.
- FDA Commissioner Scott Gottlieb and device center chief Jeff Shuren argue the changes will help modernize the 510(k) program, first put into place in 1976. "Advances in material science, digital health, 3D printing and other technologies continue to drive an unparalleled period of invention in medical devices. It's vital that the FDA's regulatory approach continue to evolve and modernize to safely and efficiently advance these opportunities," they said in a statement.
The slate of proposals comes as the agency is under fire from multiple enterprise reports from the International Consortium of Investigative Journalists for what they characterize as too lax oversight of the medical device industry and its products.
FDA pushed back on the report's assertions it has abdicated responsibilities overseeing the medical device industry.
In Monday's proposal, the agency pointed to the 1,477 predicate devices it has up-classified since 2012 as evidence that it has recently become more aggressive in its use of overseeing authority, noting that the process to do so "is time- and resource-intensive."
"To be clear, we don't believe devices that rely on old predicates are unsafe, or that older devices need to be removed from the market. However, we believe that encouraging product developers to use more modern predicates would give patients and their doctors a choice among older and newer versions of a type of device, promote greater competition to adopt modern features that improve safety and performance, and help make sure that newer devices reflect more modern technology and standards that can improve patient care and outcomes," Gottlieb and Shuren said.
AdvaMed CEO Scott Whitaker told MedTech Dive in a statement that the device industry is willing to work with FDA, but hedged against some of its proposals.
"It is our hope that through the regulatory review, the agency will recognize that in some cases there are legitimate reasons for using older predicates, and that for some devices where the technology has changed little using those older predicates still makes sense,” Whitaker said. “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."
Mike Carome, director of Public Citizen's Health Research Group, said that it is clear there are some items FDA can move ahead with, such as its proposal to publicly list cleared devices that relied on substantial equivalence to an older predicate device, while other ideas, such as limiting use of older predicate devices, will require Congress to step in.
"For that type of transparency, people can probably find that information on their own, but it would not be easy. For FDA to put together a list like that, I think that is something that they could do without congressional action," Carome told MedTech Dive. "They also talk about no longer allowing older predicate devices to be used to establish substantial equivalence under the 510(k) pathway. That I think is one area where congressional action may be required."
Last week FDA released an update to its Medical Device Safety Action Plan, saying that its effort to stand up National Evaluation System for health Technology (NEST) would benefit from $46 million in funding requested in the president's budget for fiscal year 2019. But it is unclear how quickly Congress is poised to act on its fiscal year 2019 agriculture appropriations bill that contains FDA funding in the coming weeks.
Gottlieb and Shuren have consistently spoken about the need for the funding for NEST, saying it would help the agency more quickly react to device-adverse events. The system, they claim, will help shift FDA from a postmarket surveillance system that is prone to underreporting to one that more actively monitors adverse events linked to specific devices.