Petition Argues FDA’s CDS Software Guidance Violates The Law

CDS Coalition legal counsel Bradley Thompson broke down the citizen petition calling for the US FDA to rescind the Clinical Decision Software guidance based on legal and procedural violations.

• Source: Shutterstock

The Food and Drug Administration’s Clinical Decision Support (CDS) Software guidance published 18 September 2022 violated procedural law and should be rescinded, said CDS Coalition legal counsel Bradley Thompson.

The CDS Coalition is an independent organization of software developers, patient advocates and healthcare providers created to ensure an effective regulatory system for CDS software that promotes safety without...

More from Regulation

More from Policy & Regulation