FDA Week - 01/11/2019

FDA Device Experts: LDTs, Cybersecurity Among Top Concerns In 2019

January 07, 2019
Medical device experts say that crafting new regulatory frameworks for laboratory developed tests (LDTs), digital health apps and medical device cybersecurity are among the top FDA-related issues they will be tracking in 2019. Other issues include device servicing, 510(k) modernization and the de novo proposed rule. “This list is not exhaustive, yet it’s clear FDA will be busy,” writes Aaron Josephson, senior director at ML Strategies and a former senior policy advisor at FDA’s device center, in a December blog...

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