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Expert: New Guidance May Demand Clinical Decision Support Software Re-Evaluation

 
• By Hannah Daniel

Businesses should reevaluate the classification of their clinical decision software based on a new FDA guidance, Kyle Faget of Foley & Lardner LLP tells Medtech Insight.

• Source: Shutterstock

Clinical decision software (CDS) manufacturers may be “upset” due to necessary re-evaluation from the Food and Drug Administration’s final draft guidance on CDS, says Foley and Lardner partner Kyle Faget.

Faget, co-chair of the firm’s healthcare and life science practice groups, spoke to MedTech Insight about the new guidance and her advice for CDS manufacturers.

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