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CDS Final Guidance Draws More Criticism, This Time From Congress

 
• By Hannah Daniel

Senator Bill Cassidy says FDA “disregarded” Congressional intent by expanding its authority to regulate clinical decision support software.

• Source: Shutterstock

Senator Bill Cassidy’s (R-LA) letter to the US Food and Drug administration calls into question the agency’s statutory authority to regulate clinical decision support (CDS) software as a medical device.

The agency “threatens to undermine the effective use of [CDS] tools with its September 2022 final guidance,” Cassidy said.

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