US FDA to modernise medical device approval process

27 November 2018 (Last Updated November 27th, 2018 12:12)

The US Food and Drug Administration (FDA) is planning to modernise the medical device clearance process in a bid to address the complexity of new technologies.

US FDA to modernise medical device approval process
FDA plans to amend 510(k) pathway, the medical device approval process. Credit: WIPO/Emmanuel Berrod.

The US Food and Drug Administration (FDA) is planning to modernise the medical device clearance process in a bid to address the complexity of new technologies.

The plans are intended to change the 510(k) clearance pathway, through which FDA reviews the majority of devices.

The announcement comes a day after a global investigation found serious lapses in the medical device approval process.

According to the FDA, the advancement in technologies has made the review of safety and effectiveness more challenging.

“The plans are intended to change the 510(k) clearance pathway, through which FDA reviews the majority of devices.”

The new Medical Device Safety Action Plan is expected to offer a new pathway to test the devices maintaining FDA’s safety standards.

It includes the adoption of modern safety and performance criteria to assess the devices as well as the removal of older predicates in testing.

FDA in its statement said: “We believe that where appropriate, new medical devices that come to market under the 510(k) pathway should either account for advances in technology or demonstrate that they meet more modern safety and performance criteria.

“We want to make sure that new devices are evaluated against advances in technology that can improve patient safety and performance.”

The 510(k) pathway is used to clear low- to moderate-risk devices which serve an equivalent purpose for a device already on the market.

It is said to be the most commonly used device premarket review pathway.

In 2017, FDA’s the Center for Devices and Radiological Health (CDRH) cleared nearly 82% of all approved medical devices through the 510(k) pathway.

FDA proposed the new changes on the pathway after accounting all the improvements to the 510(k) review process carried out in recent years.

In the last one decade, FDA is said to have taken multiple measures to increase the predictability and transparency of the 510(k) review process.

By early next year, FDA plans to finalise the guidance and devise an alternative 510(k) pathway.