| | As we look ahead this year, it is important to pause and reflect on the important milestones the U.S. Food and Drug Administration 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 ("authorized") a record high of 132 novel medical devices in 2020, surpassing the 40-year high mark we set in 2017 and capping off 10 years of progress. It is a big leap from the 29 novel devices we authorized a decade ago, in 2010. Novel devices include those brought to market through the premarket approval (PMA), humanitarian device exemption (HDE), and De Novo pathways, as well as a subset of those that are brought to market with 510(k) clearance or Emergency Use Authorization (EUA). Of the thousands of 510(k) clearances every year, the FDA considers only those devices with a breakthrough designation to be novel. In addition, in 2020, we are including first-of-a-kind devices authorized under our EUA authority as novel devices. Novel or innovative does not simply mean "new." They address an unmet need, or may be safer or more effective than currently available alternatives. For FDA-approved and FDA-cleared medical devices, innovation, and safety are two sides of the same coin. | | | |
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