Artificial Intelligence/Machine Learning-enabled

Working Group Chair(s)
Gabriela Commatteo
Medicines and Healthcare products Regulatory Agency (MHRA)
United Kingdom
Danielle Faruq
Food and Drug Administration (US FDA)
United States of America
Membership
Regulators and Industry Stakeholders
Status
Current

Artificial Intelligence/Machine Learning-enabled (AI/ML) medical devices bring unique opportunities and regulatory considerations when advancing public health. The AI/ML Working Group (WG) seeks to prioritize consensus in the AI/ML sector, where rapid technological advancements and an influx of manufacturers from sectors beyond medical devices is seen. Regulatory consensus for AI/ML has a close interplay with Software as a Medical Device (SaMD) for many jurisdictions, it’s therefore also a priority to maintain alignment with broader software guidance.

The goal of the AI/ML WG is to develop new documentation on the topic of Good Machine Learning Practice (GMLP), to provide internationally harmonized principles to help promote the development of safe and effective artificial intelligence/machine learning -enabled (AI/ML) medical devices.

For AI/ML WG enquiries, please email imdrf-aiwg@fda.hhs.gov.

 

Work items

AI/ML-enabled WG Technical Framework for AI Lifecycle Management

Develop a new document on the topic of artificial intelligence (AI) lifecycle management, to provide an internationally harmonized technical framework to help promote responsible innovation, health equity, and patient-centricity by facilitating the secure, safe, ethical, and effective development, deployment, maintenance, and use of AI-enabled medical device software.

Participants

Dr Paulyne Wairimu
Pharmacy Board of Kenya

Dr. José Atilio Méndez
National Administration of Drugs, Food and Medical Devices (ANMAT)
Sebastián Ocampo
National Administration of Drugs, Food and Medical Devices (ANMAT)

Dr David Hau
Therapeutic Goods Administration (TGA)
Olivia Reeves
Therapeutic Goods Administration (TGA)

Mr Francisco Iran Cartaxo Barbosa
Brazilian Health Regulatory Agency (ANVISA)
Mr Jangley Bahia Costa
Brazilian Health Regulatory Agency (ANVISA)

Janet Hendry
Health Canada
Martina Buljan
Health Canada

Dhanashree Gokhale
Health Products Regulatory Authority (HPRA), Ireland
Mariana Madureira
National Authority of Medicines and Health Products, I.P. (INFARMED)
Nada Alkhayat
European Commission
Steffen Buchholz
Germany Federal Ministry of Health (BMG)

Camille Vidal
GE Healthcare
Martin Meyer
Siemens Healthineers
Naoki Morooka
Shimadzu Corporation

Akimasa Takeuchi
Canon Medical Systems
Diane Johnson
Johnson & Johnson Medical
Patricia Krantz-Zuppan
Medtronic
Sanziana Negreanu Arboreanu
Johnson & Johnson Medical

Inbar Amuts Shushan
Ministry of Health (Israel)
Ran Milman
Ministry of Health (Israel)

Mr Kuniki Imagawa
Pharmaceuticals and Medical Devices Agency (PMDA)

José Ogaz Pérez
Public Health Institute (ISP) Chile
Yamila Cedeño Valdés
Regulatory Authority of Medicines, Equipment and Medical Devices of the Republic of Cuba (CECMED)
Yusniel Pérez Reyes
Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (CECMED) Cuba)

Mr Anle Lin
Health Sciences Authority (HSA)

Dr Dimakatso Mathibe
South African Health Products Regulatory Authority (SAHPRA)
Khanyisile Nkuku
South African Health Products Regulatory Authority (SAHPRA)

Mr Hyun-Soo Kim
Ministry of Food and Drug Safety (MFDS)
Ms Ki-Na Kim
Ministry of Food and Drug Safety (MFDS)

Dr Marie Müller
Swissmedic
Mr Nicolás Löffler-Pérez González
Swissmedic

Mr Chih-Chung Chien
Taiwan Food and Drug Administration (TFDA)
Ms Tzu-Yun Yang
Taiwan Food and Drug Administration (TFDA)

Azad Hussain
Medicines and Healthcare products Regulatory Agency (MHRA)
Molly Davies
Medicines and Healthcare products Regulatory Agency (MHRA)

Hannah Rosenfeld
Food and Drug Administration (US FDA)
Shawn Forrest
Food and Drug Administration (US FDA)