The virtual AAMI/FDA/BSI International Conference on Medical Devices (the ISC) will be presented from 10:30 a.m. to 3:15 p.m. (EDT), Monday-Wednesday 18-20 October 2021. As always, the ISC will be a dynamic review of recent changes and a look to what’s ahead in health tech standards and regulation, but this year each day will have a different focus.
The first day will look at U.S. developments, starting with a keynote address by Dr. Jeff Shuren, Director of the U.S. FDA/Center for Devices and Radiological Health, on ensuring safety and effectiveness across the product lifecycle. Other sessions led by FDA leaders and others will address patient engagement and input into standards and regulations and will provide an update on the work of the FDA’s Digital Health Center of Excellence. Finally, a panel of experts from industry and the FDA will examine what the COVID-19 Pandemic has revealed about the strengths and limitations of the U.S. medical device sector and discuss what this might mean for the future.
The second day will have a global focus, with key European regulators and industry leaders reporting on the implementation of the EU Medical Device Directives and the UK MHRA’s developing post-Brexit regulatory framework. An update on the efforts of the IMDRF to promote global regulatory harmonization will be presented. Another session will spotlight concerning developments in Indian medical device regulations and standards adoption. Finally, leaders of the Inter-American Coalition for Regulatory Convergence for the Medical Technology Sector will review their efforts to bring together industry, government, health care professionals, providers, patients, and standardization bodies across the Western Hemisphere to promote medical device regulatory and standards convergence.
The third day will concentrate on critical technologies, beginning with a second keynote address by Dr Jesse M. Ehrenfeld, MD, MPH, a dual board-certified anesthesiologist and informaticist who serves on the AMA Board of Trustees, on the looming challenge posed by the continued growth and availability of digital health AI for both regulators and consumers. Additional sessions will highlight regulatory and standards news on cyber-security issues, combination products, the use of cloud computing with medical devices, Unique Device Identifiers, and artificial intelligence.