ARTICLE SUMMARY:
In this week’s roundup: Europe posts important guide to regulating at device-drug borderlines; CMS inpatient payment rule tidbits; device servicers push back on remanufacturing bill; senator scrutinizes FDA TAP pilot; real-world evidence guides from China and Taiwan, and more.
Top Pick: EU Borderlines
Finding the regulatory borderline between medical devices and drugs is the focus of a new 27-page guidance document from the EU Medical Device Coordination Group. The guide is intended to clarify updated considerations for teasing when appropriate rules are necessary now that the EU Medical Device Regulation is in place. It includes a focus on single-entity products that could cause classification confusion including herbal products and “substance-based medical devices,” as well as device-medicine combination products. The guidance includes a flowchart for determining the regulatory status of combination products that turns in part on whether the product consists of a device intended to administer a drug and whether it is a “single integral product.”
