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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support (CDS) software, some criticized the agency for taking a much broader approach than it had laid out in its draft guidance a few years prior.

As legal experts told Medtech Insight in October 2022 after the agency published its final document, developers relying on the 2019 guidance might be caught off guard by the new...

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