Pathways’ Picks January 13: HHS on Overdrive, EU Remote Audits, and More

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ARTICLE SUMMARY:

In this week’s roundup: MCIT rule makes it through; outgoing HHS unveils surprise 510(k) exemptions and more midnight policies; FDA loses chief counsel and deputy commissioner and advances artificial intelligence policy; Europe allows remote MDR audits and designates a new notified body; BD’s Lutonix paclitaxel balloon gets a panel date; California covers CGM; and Australia considers iliac artery devices.

The chaos in Washington, DC, in the closing weeks of the Trump administration doesn’t seem to have prevented outgoing leaders of the Health and Human Services from active 11th-hour policymaking. That has resulted in the rapid finalization of one of the device industry’s top US policy priorities—the Medicare Coverage of Innovative Technology (MCIT) final rule. It also has led to some less expected policy documents that stakeholders worry encroach on FDA’s autonomy. Meanwhile, the European Commission made an important concession to COVID-19-era MDR and IVDR compliance challenges. Those items and more in this week’s Pathways’ Picks.

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