Will Tenbarge

This program will cover FDA's new QMSR regulation and the impact that it is having on FDA enforcement actions. The session will also cover new Pharma regulatory trends and enforcement priorities. Covering both device and pharma, the goal will be to educate in-house lawyers on the key regulatory and legal impacts associated with FDA enforcement authorities, policies and current priorities.

Begin the analysis with intended use One of the clearest themes in FDA's draft AI guidance is that the intended use of an AI system is at the center of regulatory expectations. The agency is less concerned about whether a tool is labeled “AI” and more focused on what the tool is being asked to do, whether the tool is fit-for-purpose for that task, and how its outputs will be relied upon.

Key provisions The 15-Business-day window Manufacturers should respond within 15 business days of receiving a Form 483. FDA will not ordinarily delay regulatory action—including a Warning Letter—to review a late response. A single consolidated response is preferred. Where complex observations cannot be fully resolved in time, FDA expects at minimum a corrective and preventive action (CAPA) plan and proposed timeline submitted within the window.