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International

FDA unveils 2019 blueprint after setting device approval record

28/03/2019
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The US Food and Drug Administration (FDA) is this year broadening its framework to drive innovation, after approving a record number of medical devices in 2018, including several ophthalmic products.

In setting the FDA’s 2019 agenda, commissioner Dr Scott Gottlieb said the agency wanted to continue progressing, and build on the 106 novel devices that were granted approval last year. The number surpassed the organisation’s previous record set in 2017, when 99 products were cleared.

New ophthalmic devices featured prominently among novel devices last year, including; technologies using artificial intelligence to detect diabetic retinopathy; the first artificial iris in the US; and the permitted marketing of a new prescription medical device that measures eye movement to assist in diagnosing concussion.

“It’s vital that the FDA’s regulatory approach continue to evolve and modernise to safely and efficiently advance these opportunities. Not only must we keep pace with this complexity and innovation, but we must also stay ahead of the new and evolving risks that can sometimes accompany novel products,” Gottlieb said.

AFT Pharmaceuticals
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