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US FDA approves fewer innovative medical devices in 2018

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US FDA approves fewer innovative medical devices in 2018

The U.S. Food and Drug Administration's approval of innovative medical devices fell from a record high of last year, though the regulator made efforts to ease regulations for other types of products.

The regulator signed off on 31 original premarket approvals, or PMAs, in 2018 compared to the decade high of 46 in 2017. A manufacturer is required to submit a pre-market application if a device is high risk and completely new to the market, resulting in greater scrutiny from the regulator.

In 2018, these included the first ever artificial iris from Germany's HumanOptics AG's; a more efficient breast cancer test from Endomagnetics Ltd.; newer continuous glucose monitoring, or CGM, systems; and a lung implant, among others.

In tandem, the FDA cleared a record-setting 44 de novo applications in 2018, a regulatory process reserved for products that have a moderate risk and do not require as much scrutiny as PMAs.

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Other PMA approvals in 2018 included Glaukos Corp.'s iStent to reduce fluid pressure among patients with glaucoma, a type of vision loss. The San Clemente, Calif.-based company believes its product is the smallest medical device ever approved by the FDA.

The agency also approved several CGM systems, including Medtronic PLC's Guardian monitoring system, which alerts diabetes patients of potential high or low glucose events up to 60 minutes in advance. The year also saw the approval of several stents used to unblock blood vessels, such as Boston Scientific Corp.'s drug-coated stent Eluvia to treat peripheral artery disease.

The FDA has not made any changes that would result in lower PMA approvals in 2019, Cowen & Co. analyst Eric Assaraf told S&P Global Market Intelligence. A July 2018 report from data research firm Evaluate also said there were no changes to regulatory processes that would make it harder to register devices.

PMAs are already understood to take a longer time, cost more money in user fees and have stricter review procedures.

The de novo pathway has gained popularity since the FDA simplified its rules in 2012, Evaluate said in its report. The agency has approved 235 novel devices since the inception of this pathway in 1997, out of which more than half have been cleared after 2012, according to FDA data.

In 2018, several trailblazing approvals under this category included first-of-its-kind "self-fitting" hearing aids from Bose Corp. and IDx LLC's IDx-DR, the first artificial intelligence-based medical device to detect a higher severity of diabetic retinopathy, an eye disease.

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Regulatory changes

The FDA is taking steps to simplify its complicated medical device regulation to speed up the de novo medical device approvals as well as raise standards for the 510(k) pathway. The 510(k) pathway is more relaxed and accounts for the majority of the medical device approvals in the U.S.

Under the 510(k) rule, the agency can approve a device if it is demonstrated to be equivalent to an already FDA-approved product, also called predicate device. The regulator is planning to launch new rules that would require the companies to establish equivalence with devices that are 10 years old or newer.

The agency also plans to further streamline the de novo pathway, which does not involve a predicate, by clarifying the requirements for submission and processes for review.

However, the regulatory overhaul in the de novo and 510(k) pathways is not expected to spill over into the PMA process. Since FDA is planning to modernize the 510(k) program in 2019, there is a very low probability of PMAs being impacted this year, Assaraf said.