510(k) Modernization: FDA Floats Need to Pursue New Authority

Regulatory NewsRegulatory News | 28 January 2019 |  By 

Plans at the US Food and Drug Administration (FDA) to “modernize” the most commonly used pathway for new medical device clearances “might require new authority,” FDA leadership said on Monday.

FDA Commissioner Scott Gottlieb and Jeff Shuren, director of FDA’s Center for Devices and Radiological Health (CDRH), issued a joint statement to announce 2018 progress on novel device approvals, pointing out that the breakthrough 510(k) is one of two submission types that was newly added to the definition of a novel device. Humanitarian device exemptions (HDEs) were added to the novel device definition also, following changes the 21st Century Cures Act of 2016 made to CDRH’s Breakthrough Device program.

The statement marked the first time that FDA officials publicly acknowledged a potential need to pursue new authority as part of its proposed plans for modernizing the 510(k) process. It comes after the 510(k) modernization plans drew public scrutiny last November, partly over FDA’s current authorities.

The proposal is centered on limiting use of predicate devices to those that are no more than 10 years old to demonstrate substantial equivalence, though certain concerns around the potential impact on industry innovation remain as well. Industry pushback also cited arbitrary decisions on predicate use.

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,” Bradley Merrill Thompson, an attorney at Washington-based law firm Epstein Becker Green, said in a recent comment to FDA. In his comment, Thompson referred to a new option for sponsors to seek 510(k) clearance in addition to traditional, abbreviated and special 510(k) submissions.

Combining the agency’s push for a limited use of older predicate devices in the traditional 510(k) pathway with that of the new Safety and Performance Based Pathway for 510(k) clearance created some confusion around the connection between the two proposals. The connection relates to encouraging use of modern device performance criteria among sponsors seeking 510(k) clearance, with CDRH maintaining that the goal is for the alternative option to become the main pathway for device clearances. CDRH finalized guidance on the new Safety and Performance Based Pathway just last week.

The agency’s goals with 510(k) modernization relate to advancing innovation and driving competition in the medical device space. “One measure of our success in advancing device innovation is the annual number of novel, safe and effective technologies the FDA approves or clears,” Gottlieb and Shuren said.

2018 marked another record year for novel device approvals, with a total of 106 compared to 98 in 2017. The yearly increases in novel device approvals since 2014 is depicted in the graphic below.


These efforts speak to a measure of success CDRH set last year to have 50% of manufacturers of novel devices come to the US first or in parallel with other major markets.



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