Warning Letter Roundup & Recap – January 2023

The US Food and Drug Administration published three device-related warning letters in January – two that went to divisions of endoscope vendor Olympus, and one to a Maryland vision treatment firm.

Warning Rubber Stamp

Check out Medtech Insight's US FDA Warning Letter Data Tracker here.

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Switzerland Investigates Private Sector Assessment of FDA-Approved Medical Devices

 

Its move comes as the Swiss recognize the need to ensure adequate supplies on medical devices in its country.

Medtech Seeks Inclusion In EU’s Groundbreaking Life Sciences Strategy

 

As the EU Life Sciences Strategy aims to drive innovation, the medtech sector is pushing for a pivotal role in a mission intended to embrace green and digital transitions, address regulatory obstacles and reduce dependency on external sources.

‘The FDA Will Be Looking For Avenues To Regulate Laboratory Developed Tests’

 

The FDA's final LDT ruling was struck down in federal court last month. For now, diagnostic companies can commercialize under CLIA regulations or apply for FDA approval. McDermott and Tribun Health have shared insights on the risks, pros and cons of both regulatory routes.

Update: Italy’s IMQ And Belgium’s SGS Named 15th and 16th IVDR Notified Bodies

 

Ireland’s NSAI reinstated under IVD Regulation designation list

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