Critics cite lack of risk-based enforcement approach, unclear criteria as problematic . . .

Medical Device Experts Criticize FDA's Clinical Decision Support Draft Guide

By Beth Wang / December 21, 2017 at 5:08 PM
Legal experts representing the clinical decision support (CDS) software industry take strong issue with FDA's draft guidance on CDS software, published Dec. 7. The experts complain that FDA's guidance doesn't adopt a risk-based enforcement approach, fails to provide meaningful examples and explanations of regulated and unregulated software, and is unclear when it comes to the criteria for determining when CDS will be regulated. FDA's CDS software draft guidance clarifies the types of CDS tools that under the provisions in the...

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