Unpacking FDA's Final Clinical Decision Support Guidance

The U.S. Food and Drug Administration (FDA) recently issued a final guidance document clarifying how the agency intends to regulate clinical decision support software (CDS). How has this document caused confusion for industry? How can companies respond? On this episode, Epstein Becker Green attorneys Brad Thompson and Jessika Tuazon analyze the FDA's latest CDS guidance and discuss the challenges industry faces as it attempts to make sense of, and comply, with that guidance.   Visit our site for related resources and email contact information: https://www.ebglaw.com/dhc57.   Subscribe for email notifications: https://www.ebglaw.com/subscribe.   Visit: http://diagnosinghealthcare.com.   The EMPLOYMENT LAW THIS WEEK® and DIAGNOSING HEALTH CARE podcasts are presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.