MDIC Digital Health Initiative Could Be Crucial To FDA Pre-Cert Program
The public-private partnership has launched an initiative that aims to help regulators address digital health – in particular the US FDA’s pre-cert pathway for certain medical software.
You may also be interested in...
Digital Health Roundup, August/September 2021: Record Digital Health Funding Q1-3 Of $21.3Bn, AAOS Highlights, Regulatory Updates
In this roundup of developments in digital health, we highlight the key news and announcements from August and September.
The document from the Medical Device Innovation Consortium aggregates external data sources, various statistical methods and lays out other considerations for sponsors to help speed up and bolster a premarket product application to the US FDA.
US FDA says as artificial intelligence and machine learning offer new opportunities to improve patient care, the agency hopes to encourage innovation by developing a draft guidance on the issue for sponsors. It also released a discussion paper outlining key issues it wants feedback on from industry and other key stakeholders.