Experts Question Impact on Innovation, FDA Authority to Pursue Revamp of 510(k) Pathway

Regulatory NewsRegulatory News | 27 November 2018 |  By 

Following Monday’s announcement from the US Food and Drug Administration (FDA) on its plans to remodel one of the review pathways for medical devices, industry trade associations pushed back on certain parts of the proposal that may hinder innovation.

AdvaMed and the Medical Device Manufacturer Association (MDMA), among others, expressed mixed reactions to FDA’s policy proposals for modernization of the decades-old 510(k) framework. The device groups agreed with FDA on the 510(k) pathway being a crucial component of its gold standard for safety.

But AdvaMed President and CEO Scott Whitaker argued “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.”

MDMA’s concerns relate to the potential impact on innovation as well. “We must be vigilant that any changes made to a system that has worked so well for so many patients carefully balances safety and innovation, and does not adversely impact America’s innovators as they seek to improve patient care,” argued MDMA President and CEO Mark Leahey.

FDA intends to offer industry the opportunity to voice concerns around the use of older predicate devices prior to making public a new list of previously cleared devices for which firms demonstrated substantial equivalence to existing predicates that are more than 10 years old on the Center for Devices and Radiological Health (CDRH) website.

Michael Morton, principal consultant at MC Morton Regulatory Consulting, praised the agency from a high-level perspective for its efforts to modernize the 510(k) process, but argued "it is difficult to see how anyone in the patient or medical community would benefit" from publishing the list of devices recently cleared based on older predicates. "Most sponsors are going to use predicates that have got the latest technology anyway because they want to put out the best product for patients and remain competitive in the marketplace," he told Focus.

Abbreviated 510(k)

The agency first notified of its intentions to expand on its voluntary Abbreviated 510(k) program as an alternative clearance option through its medical device safety action plan, released in April. At the center of industry concerns lies the shared belief that an abbreviated 510(k) offers little to no benefit at the manufacturer level compared to a traditional 510(k) submission. This is because a traditional 510(k) allows for more flexibility in demonstrating substantial equivalence vs. an abbreviated 510(k) approach.

The argument for use of abbreviated 510(k)s relates to the reliance on FDA-identified performance criteria—as opposed to direct comparisons—to demonstrate substantial equivalence. FDA issued draft guidance in April to outline proposed expansion changes. Pending the final version set for early 2019, the draft guidance left device groups puzzled. “It is somewhat difficult to determine the impact of this effort,” AdvaMed VP of Technology and Regulatory Affairs Ruey Dempsey said in a submitted comment.

Morton, who previously served as Medtronic's VP of corporate regulatory affairs, argued use of an abbreviated 510(k) "has real promise" but its "value only puts more emphasis upon consensus standards," which have yet to cover all devices for which 510(k) clearance is sought. "There is often a combined effort to use traditional 510(k) while relying heavily on consensus standards," he noted. Yet CDRH's new initiative intends to better support newer technologies and "those are the technologies that don’t quite have consensus standards yet."

Yet CDRH remains firm on its plan, which involves renaming the newly proposed 510(k) approach the “Safety and Performance Based Pathway” in order to “reflect its focus on advancing improved safety and performance of new products,” FDA spokesperson Deborah Kotz told Focus. “Through this new path, a company would demonstrate that a novel device meets modern performance-based criteria that have been established or recognized by FDA and reflect current technological principles,” Kotz added.

Local and Global Impact

The “Safety and Performance Based Pathway” includes several other changes to the existing 510(k) framework, such as sunsetting older predicates. The market-based approach “is the future of the 510(k) program,” FDA Commissioner Gottlieb and CDRH Director Jeff Shuren argued, citing the need to keep pace with increasingly complex devices. They also noted, however, that “some of these proposals may require additional support from Congress,” though the agency has yet to determine whether the new 510(k) approach “should become a requirement in the future.”

Statutory and regulatory authorities for pursuit of the policy changes has led turmoil among experts.

Bradley Merrill Thompson, an attorney at Washington-based law firm Epstein Becker Green, called the commitment set forth via the new medical device action plan on the alternative pathway “perhaps the most egregious example of violating the statute,” according to a recent comment submitted to FDA.

The 510(k) pathway “is the law of the land, and FDA doesn’t have the right to turn its back on the law and create a new system,” Thompson said. “The present system is the way that it is in part because of the concern over limiting agency authority due to its tendency to be unduly conservative an inherent subjectivity of decision-making. The system FDA describes has no limits on its own authority.”

Morton echoed some of Thompson's concerns and offered a solution to bridge the gap between abbreviated vs. traditional 510(k) to transition to the new framework. He suggested FDA shifts focus away from establishing whether a device is safer or more effective than another toward promoting innovation in the market. Sponsors have the right to choose to use an older predicate and FDA has the responsibility, if the device is safe and effective, to put it on the market." Morton also recommends taking a more collaborative approach to promote greater use of more recent predicates through open dialogue with agency staff prior to submitting 510(k)s. 

Meanwhile, CDRH has continued to push for a global medical device single review program (MDSRP) in collaboration with the International Medical Devices Regulators Forum (IMDRF). MDSRP, if adopted, would impact device premarket notification requirements in that it would become a mechanism for IMDRF member countries to rely on submissions in whole or in part for regulatory decision-making.

CDRH recently launched a pilot program to asses proposed policy changes for expanding eligibility in its special 510(k) program, which provides the review pathway for clearance on changes to a manufacturer's own device. The Medical Device Academy believes it will also seek to pilot the proposed 510(k) framework.


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