FDA Updates Its Criteria For Medicare Coverage Of Device Trials
This article was originally published in The Gray Sheet
Executive Summary
The agency has long been partnering with CMS to set coverage for investigational device exemption studies by designating IDE trials as "category A" or "category B." A new FDA draft guidance and memorandum of understanding between FDA and CMS are intended to modernize the criteria for those trial categories.
You may also be interested in...
FDA Updates IDE Guidance Addressing Medicare Coverage
CMS may have an easier time determining when it should pay for an investigational device as FDA revamps its IDE device-classification scheme.
FDA Abandons Proposal For Interactive, “Pre-Decisional” IDE
The agency finalized a guidance document on investigational device exemption review decisions, dropping a proposal to establish a new, interactive “pre-decisional” IDE process. Industry had been skeptical that the proposed program would improve efficiency of study reviews, and worries that it would require a lot of FDA resources.
US FDA’s Anti-Misinformation Campaigns Look Safer After Supreme Court Oral Arguments
FDA’s efforts to tackle misinformation may face fewer legal obstacles moving forward, following oral arguments at the Supreme Court on a case that could have broad ramifications for how the government communicates public health information.