Becky Wood in Washington, D.C., Emily Marden in Palo Alto, and Josefine Sommer in Brussels look at new FDA guidance on the use of real-world data to support new indications and post-approval study requirements.
Elizabeth Curtin in Chicago and Jonathan Tomlin in London consider why any litigation arising over medtech that uses AI is likely to become complex. They consider how manufacturers of AI can support physicians’ medical judgments and help guard against the danger that they might themselves inadvertently become ‘insurers’ of medical outcomes.
Prior to their webinar on Thursday, October 7, Coleen Klasmeier and Jaime Jones consider some of the effects of the final rule.
FDA’s final rule to amend its medical product ‘intended use’ regulations has now been in effect since September 1. The changes which the final rule makes to the definition of intended use, as interpreted by FDA in the accompanying preambles, expand the types of evidence that are deemed relevant to determining whether a lawfully marketed drug or device has a new intended use and whether a product is intended for use as a drug or device.