Pathways' Pick of the Week: A Record Year for Novel Devices

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ARTICLE SUMMARY:

CDRH approved a record number of novel devices in 2023. Excerpted from Pathways' Picks January 17: “China on Real-World Studies, IMDRF Heads to DC, Medicare Picks, and EU News.

FDA’s device center authorized 124 devices that it categorizes as “novel” in 2023, “the highest number of novel medical devices on record,” CDRH announced in the January 17 release of its 2023 annual report. The novel device count, which excludes emergency use authorizations, totals original and panel-track PMAs, De Novos, original Humanitarian Device Exemptions, and Breakthrough Device 510(k) clearances. A few other factoids from the annual report:

  • CDRH authorized (PMA, De Novo, and 510(k) 29 Breakthrough Devices in 2023, the most since the program was launched;  
  • 21 device have transitioned from EUAs to traditional marketing authorizations; and
  • All 141 positions funded by MDUFA V for FY 2023 were filed.
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