ARTICLE SUMMARY:
In this week’s Pathways Picks: CMS-FDA RAPID proposal could be out this month; FDA issues draft guide on payor communications, and final guidance on human factors testing; China establishes standard framework for reclassifications; South Africa outlines what’s expected for electronic instructions for use; and more from South Korea, Europe, and the US.
US Picks
RAPID watch, payor comms, human factors guide:
RAPID proposal this month? CMS and FDA announced plans for their new accelerated coverage pathway for Breakthrough Devices more than a month ago, but have yet to issue an official proposal that lays out the details and provides an opportunity for public comment. That proposal, for the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway, should be coming in the Federal Register within the next 30 days, says Mark Leahey, CEO of the Medical Device Manufacturers Association, who attended a special briefing with agency officials when plans for RAPID were announced in April. “Our hope is that by the end of this calendar year you will have a RAPID program that's operational,” Leahey said during a June 2 panel discussion at the MedTech MVP Venture and Partnering Conference in Minneapolis. As Market Pathways reported in April, the vision is for makers of devices selected for RAPID to engage with both agencies in the pre-IDE stage. The goal would be to design a pivotal trial/evidence plan that gives CMS the data it needs to propose a national coverage determination on the same day a device is authorized by FDA, and then finalize the NCD within three months.
