CDRH Begins Reorganization Towards Team-Based Approach

CDRH has launched a major shakeup that will create several new offices—including one “super office” for product evaluation and quality. Read More

Australia Proposes New Device Classifications to Align With EU Regs

Australia’s TGA released five new draft guidances that propose changes to the classification of numerous medical devices to align more closely with European Union regulations. Read More

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