FDA Proposes Reclassifying Companion Diagnostic IHC Tests to Class II

The FDA is proposing to reclassify immunohistochemistry (IHC) test systems used with approved oncology therapeutics from class III (premarket approval) to class II (special controls), subject to premarket notification. This regulatory shift would reduce the regulatory burden for companion diagnostics, potentially accelerating market access. The proposal is open for comment and not yet final, so the impact depends on the rulemaking outcome.

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