‘Refuse to Accept’ Decisions For Cyber Devices To Begin In October
The US FDA is giving sponsors a grace period of six months before it will issue “refuse to accept” decisions for premarket submissions for cyber devices that lack the information required under recent cyber amendments.
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News We’re Watching: Abbott FreeStyle Libre Recall, Medtronic Partners With DaVita, Free SBOM Software
This week, Abbott announced a class I recall of several glucose management systems. Additionally, Medtronic announced partnerships with DaVita and Qure.Ai; Heartflow closed a funding round; and BiVacor readies for artificial heart trials.
How Proactive Cybersecurity Can Protect Insulin Pump Users
Medtech Insight spoke to MedCrypt director Naomi Schwartz about how proactive cybersecurity can ease premarket burdens for diabetes care manufacturers.
Expert: Cybersecurity Requirements In Omnibus Bill Will Provide Visibility For Industry
New cybersecurity regulations passed as part of the year-end omnibus bill included software bills of materials (SBOMs) which will provide visibility to manufacturers and regulators.