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US FDA to modernise medical device approval process

November 27, 2018

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

Read More on medicaldevice-network.com