It’s hard to believe, but medical device manufacturers who are subject to Food and Drug Administration premarket approval — the FDA process of review to evaluate the safety and effectiveness of Class III medical devices — are still operating under the FDA’s original medical device cybersecurity guidance from 2014 and a subsequent update in 2018. But that is about to change in a major way.
Instead of finalizing the 2018 premarket cybersecurity draft guidance, the FDA has decided to issue a new 2022 version to reflect the rapid evolution of cybersecurity, incorporating a new set of quality system regulations (QSRs) with significant changes to its 2018 predecessor.
