Pathways Picks January 25: EU Experts, CMS Contract, FDA-Apple Meeting, and More

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ARTICLE SUMMARY:

In this week’s roundup: Europe looks to launch MDR scientific advice pilot, and reports on expert panel scrutiny performance; EU postmarket surveillance tool assessed; new notified body; Apple meets with FDA on possible Watch ban; CMS seeks data-scanning contractor to streamline coverage; personnel news from FDA, J&J, and UK NICE; and more.

Top Picks: EU Expert Panels

Voluntary advice pilot set to launch, while mandatory opinions are assessed:

Scientific advice pilot prepped. The European Medicines Agency will launch a year-long pilot next month to give 10 makers of innovative devices the opportunity to receive early scientific feedback from EU expert panels on clinical trial planning. The goal is to facilitate the EU Medical Device Regulation assessment process for novel, high-risk devices, with some priority for small medtech firms. EU officials discussed the pilot during a January 25 session. For more details, see “EU Preps ‘Scientific Advice’ Pilot for 10 Firms Seeking MDR Approval” in Market Pathways

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