A panel of regulators and industry experts offered a variety of perspectives on artificial intelligence in medical devices and other digital health technology during the MedTech Conference in Boston.
International harmonization is essential to regulating devices that incorporate artificial intelligence and other digital technologies, according to Brendan O’Leary, acting director for the FDA’s Digital Health Center of Excellence. He explained that the approach is necessary because “you can’t have disjointed approaches to this technology across multiple jurisdictions.”
But from a regulatory angle, implementing global standards is challenging.
Ahead of the 11 June UK spending review and its anticipated funding uplift for healthcare and life sciences, the MHRA announced an expansion of its digital expertise by creating a dedicated hub in Leeds, a renowned center of medtech excellence.
FDA moves forward with implementing previous draft guidance and will consolidate forms, but the agency estimates limited impact in the total reporting burden.
The US FDA's new draft guidance details the responsibilities of new owners of 510(k) clearances, including making timely updates device listings in FURLS and GUDID to maintain accurate information for safety alerts and recalls. Comments on the draft are accepted until 4 August.
