FDA Lowers Regulatory Bar For High-Risk IVDs

The agency has announced plans to move many class III diagnostics into class II, which could be a boon for developers of companion diagnostics and tests for infectious diseases.

Diagnostic testing kit

Most high-risk in vitro diagnostics will be regulated as class II devices instead of the current class III under a US Food and Drug Administration plan announced on 31 January.

The change will mean that IVDs that once would have required PMAs to enter the US market will now only...

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