Tuesday, February 16, 2021

Reflections on a Record Year for Novel Device Innovation Despite COVID-19 Challenges

132 novel medical devices were approved, cleared, or authorized in 2020.

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US Food and Drug Administration

Reflections on a Record Year for Novel Device Innovation Despite COVID-19 Challenges

As we look ahead this year, it is important to pause and reflect on the important milestones the U.S. Food and Drug Administration (FDA) reached in 2020 to help strengthen the public health.

Among those milestones is the work the FDA's Center for Devices and Radiological Health (CDRH) accomplished in response to the COVID-19 pandemic, while keeping up with the Center's ongoing work and continuing to bring a growing portfolio of innovative devices to patients.

Most notably, the FDA approved, cleared, or authorized a record high of 132 novel medical devices in 2020, surpassing the 40-year high set in 2017 and capping off 10 years of progress. It is a big leap from the 29 novel devices the FDA authorized a decade ago, in 2010.

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