FDA Denial of Petition to Protect Marginalized Patients

The Food and Drug Administration (FDA) has denied a Citizen Petition submitted by the Center for U.S. Policy (CUSP) aimed at protecting patients from being deprived of the prescription drugs they need. The petition asked the FDA to deem a widely used clinical decision support (CDS) software a misbranded medical device and to mandate a recall to prevent serious, adverse health consequences and death.