US Policy Quick Bits: Point-Of-Care Dx, Bundling, And Chatter On The Hill

Federal agencies came out of the US Thanksgiving holiday swinging with a raft of important policy developments for the medtech space. Here's what you need to know:

CLIA waiver watch: FDA put its cards on the table for an important issue in the point-of-care diagnostics space. The agency released a highly anticipated draft guidance document on how manufacturers should go about proving "accuracy" in submissions seeking "CLIA waiver" status, the designation needed to sell a test in US point-of-care settings. IVD-makers have been complaining for years that FDA's current accuracy standard is overly burdensome and, to boot, flouts US law. Industry convinced Congress to force the agency, via the 21st Century Cures Act, to rewrite its guidelines on the topic. But early signs suggest companies are not impressed with the new guidance