Category

Regulatory insights
11
May

FDA issuing Final Rule on regulating LDT

May 11, 2024,
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07
Apr

Concerns Expressed in Public hearing Surrounding FDA’s Regulation of Lab Developed Tests (LDTs)

April 7, 2024,
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06
Mar

The EU has finally designated 5 IVDR reference laboratories

March 6, 2024
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26
Feb

Significant Gap in EU Medical Device Market Revealed, the MDCG’s Prompting Calls for Immediate Certification Applications

February 26, 2024
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