FDA sets novel device approval record for 2018, outlines new criteria for 510(k) clearances

The FDA believes the new benchmark criteria for 510(k) clearances could drive greater market competition to develop safer devices. (Andrew Harnik, AP)

Last year set a new record for FDA approvals of novel medical devices, continuing the upward trend seen over the past few years, according to the agency.

In 2018, the FDA greenlit 106 new devices—including premarket approvals and panel-track supplements; de novo and breakthrough 510(k) clearances; and humanitarian device exemptions—beating out 2017’s 40-year record of 98 devices.

Some of these include the world’s smallest mechanical heart valve, developed by Abbott and St. Jude Medical for newborns; the first blood test for detecting concussions and intracranial lesions, by Banyan Biomarkers; and the first artificial iris in the U.S., by HumanOptics.


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The agency also spotlighted the 112 breakthrough device designations it has granted since the program launched in April 2015, with nine being approved or cleared in the last calendar year.

The FDA did adopt a new definition of “novel device” beginning this year, to include HDEs and breakthrough device 510(k) clearances, following changes made by the 21st Century Cures Act passed in December 2016. However, even under the old tabulation, 2018’s 101 novel approvals still outpaced the previous year’s 95 devices.

“We need to be able to continually adapt our frameworks, try new approaches, and, where necessary, seek new authorities because science does not stand still,” said FDA Commissioner Scott Gottlieb, M.D., and CDRH Director Jeffrey Shuren, M.D., in an agency statement. “Advances in material science, digital health, 3D printing and other technologies continue to drive an unparalleled period of invention in medical devices.”

In addition, the FDA also outlined the latest steps in its plan to strength its 510(k) clearance program, including a new final guidance (PDF) for a safety- and performance-based pathway that allows manufacturers of moderate-risk devices to use a separate set of criteria in their demonstrations of substantial equivalence to already-marketed devices.

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The objective criteria, established or recognized by the agency, could be used by sponsors instead of predicate devices, which the FDA said may be older and out-of-date with more modern safety considerations and technology.

This will allow the agency to benchmark modern technology against modern standards, while potentially offering a more efficient way to market, Gottlieb and Shuren wrote in a separate statement.

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“We also believe this new approach may drive greater market competition to develop safer devices,” they added. The agency will start by issuing guidance outlining new safety and performance criteria this year for certain well-understood device types, which will be open for public comment.

Additionally, the FDA is seeking input on whether the agency should make a public list of devices and manufacturers that rely on predicate devices that have been on the market for a set number of years, such as a decade, and whether the agency could take other or alternative actions to promote safer device development.

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