Shots:

• The US FDA has planned to reclassify some of the high-risk in-vitro diagnostics (IVDs), incl. infectious disease and companion diagnostic IVDs, from class III devices to class II moderate-risk devices
• The decision will benefit IVD sponsors by allowing the use of the 510(k) pathway instead of the premarket approval (PMA) process relieving the regulatory burden
• The 3 infectious disease IVDs decided for reclassification are nucleic acid & serology-based IVDs for identifying Hepatitis B infections, serology-based IVDs to diagnose human parvovirus B19 and cell-mediated immune reactivity IVDs to identify peptide antigens linked with Mycobacterium TB infections. Others will be announced soon

Ref: FDA | Image: FDA

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