FDA Announces Enforcement Discretion to Expand Monkeypox Testing

The Food and Drug Administration will temporarily allow the Centers for Disease Control and Prevention (CDC) Laboratory Response Network laboratories and other CDC-designated laboratories to use an additional platform to expand monkeypox testing.

FDA does not intend to object to the use of the Applied Biosystems 7500 Fast Real-time PCR System (RUO instrument) with the CDC Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set under its cleared labeling and procedures and with the adoption of risk mitigations. FDA currently intends to exercise this enforcement discretion for up to three months.

Additionally, surveyors from the Centers for Medicare and Medicaid Services should not cite labs for use of this alternative testing platform if the risk mitigations are followed.

The agency announced the temporary enforcement discretion in response to an Aug. 1 request from the CDC that cited an “urgent need” to expand testing throughput beyond the CDC Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set, which FDA cleared for use in CDC-designated laboratories in June.

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