Regulatory Framework of AI/ML Enabled Medical Devices in the U.S. and EU.

Faced with novel, swiftly evolving technologies in the digital health space, Regulators worldwide are trying to balance timely access of innovation to patients with reasonable assurance of safety and effectiveness working under regulatory frameworks traditionally designed to regulate hardware medical devices. This Session will discuss:

(i) The foundational Statutory mandate (“Cures Act”) in the U.S. that provides regulatory and policy framework for FDA in regulating software utilizing AI/ML tools.

(ii) FDA’s policy evolvement following the Cures Act mandate.

(iii) FDA’s Clinical Decision Support (CDS) Software Guidance and new challenges created for medical AI/ML industry by FDA’s shifting policy paradigm signaling a move away from previous flexibilities, increased regulatory oversight, and a shift from risk based international framework.

(iv) Key considerations when evaluating AI/ML-driven devices to demonstrate compliance and to meet the intent of EU Regulations 2017/745 (MDR) and 2017/746 (IVDR).

(v) The new EU AI Act that provides more oversight on the regulation of AI/ML-enabled devices placed in the EU marketplace.

(vi) Finally, the regulatory challenges and opportunities for AI/ML enabled medical devices in the U.S. and EU.

* One lucky attendee will win a copy of RAPS Software as a Medical Device book.