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Medical device manufacturers with products in China should check their current product portfolios against a new device catalog released by China’s Food and Drug Administration to develop transitional plans if any of their devices will be reclassified. Read More
The FDA added the UL 2900 cybersecurity standard for medical devices to its list of recognized standards. The standard covers assessments of network-connectable devices for malware, software limitations and vulnerabilities. Read More
The FDA is asking stakeholders for help identifying federal requirements that can be repealed or replaced under the Trump administration’s deregulatory push. Read More