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Abiomed Letter Underscores Questions On FDA’s Clinical Decision Support Guidance

 
• By Brian Bossetta

A warning letter from the US FDA to device manufacturer Abiomed highlights industry’s criticism that the agency’s final guidance on clinical decision support software is flawed and oversteps regulatory boundaries.

Regulations
• Source: Shutterstock

When the Food and Drug Administration issued its final guidance last year on clinical decision support (CDS) software, some criticized the agency for taking a much broader approach than it had laid out in its draft guidance a few years prior.

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