FDA Publishes Final Guidance On Clinical Decision Support Software, Clarifies What Software Should Be Regulated As Medical Devices
Executive Summary
In its final document, the US FDA outlines its interpretations of the four criteria for excluding clinical decision support software from being regulated as medical devices under federal law. Software must meet all four criteria to be excluded.
You may also be interested in...
CDS Final Guidance Infringes On Free Speech, Professor Says
A citizen petition filed by a University of Florida Law Professor posits that the FDA’s CDS Guidance violates the first amendment.
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.
Real Or Fake? FDA Seeks To Clarify The Definitions Of Legitimate Medical Devices And Counterfeit Ones
The 2020 Safeguarding Therapeutics Act added the term “counterfeit devices” to the US FDA’s lexicon, giving the agency the authority to keep them out of the country or even destroy them.