brThe U.S. Food and Drug Administration (FDA) recently released its draft guidance on managing cybersecurity in medical device premarket submissions. However, leading companies such as GE Healthcare and industry groups have voiced concerns over the tiered approach, saying this will result in confusion and potential discrepancies. They want the tiered system eliminated or amended. Industry group AdvaMed said that the planned two-tier framework is “unnecessary given its superficial similarity” to FDAs risk classification scheme for medical devices.

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