‘Refuse to Accept’ Decisions For Cyber Devices To Begin In October
Executive Summary
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.
You may also be interested in...
AI Can Be A ‘Catalyst’ For Device Cybersecurity
Cybersecurity expert Seth Carmody explained how artificial intelligence can assist reviewers and developers in advancing device cybersecurity.
FDA 2024: Watch For Trial-Diversity Guidance, Final Quality Systems Rewrite
Industry observers at RAPS Convergence in Montreal last week said the FDA’s agenda for 2024 is likely to include increased emphasis on MDUFA goals, enhanced cybersecurity requirements, the new QMSR, and more.
Digital Health Roundup: VR, AI Trends In Rehabilitation; Cybersecurity Regulations; Medicare Updates
In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights VR, AI and other high tech trends in rehabilitation and gait training. Hannah Daniel discusses cybersecurity updates such as the new NIST published draft for an updated version of the Cybersecurity Framework, a recent report by Health-ISAC, and an interview with MedCrypt’s Naomi Schwartz about the upcoming FDA cybersecurity regulations for premarket approvals.