ARTICLE SUMMARY:
In this week’s Pathways Picks: FDA considers autonomous and remote robots, adds flexibility to emergency diagnostic testing, and proposes 510(k)s for more companion diagnostics; medtech and the midterms; CMS delays remote monitoring payment restrictions, finalizes pass-throughs, and adds DME latitude; EU adopts updated standards and makes a pact with Singapore; and more global policy updates.
FDA Picks
Robots, free and far afield
FDA asks for input on methods for gauging benefit and risk of robotic medical devices that operate with some level of autonomy or via remote teleoperation in a discussion paper posted November 6. The paper precedes a two-day workshop on the topic that will be held December 2 and 3 at FDA’s Maryland headquarters and virtually. “FDA is seeking to develop a regulatory approach that would rigorously and appropriately mitigate risks while championing the meaningful benefits these technologies offer,” the agency writes in the discussion paper, requesting written comments by January 5. FDA also published a draft guidance on more conventional robot-assisted surgical devices in September.
