AgencyIQ

Seven years after its inception, the FDA has finalized its first guidance on the Voluntary Malfunction Summary Report (VMSR) program for medical devices. Read our analysis here: bit.ly/4gfmB7g

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Courtney Lias has been Acting Director of CDRH’s in vitro diagnostics office, known as OHT7, since the departure of Tim Stenzel at the end of 2023. Recently she confirmed she is now the permanent Director. Read our analysis: bit.ly/3yZwGnP

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ECHA has issued a new guide for NEAs, clarifying the tiered approach to mixtures classification under the CLP Regulation and strategies for reviewing duty holders’ classifications of hazardous mixtures. Read more: bit.ly/47lmz9T

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Over a year since its initial draft guidance document on the use of PCCPs for medical devices that leverage machine learning, the agency has issued a new draft guidance on the use of PCCPs for all medical devices. Read more: bit.ly/3T12K1h

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Don't miss out! Register here: bit.ly/4dhsJd2 to join us on tomorrow, Tuesday, August 27, at 12pm ET, for a free and informative webinar where AgencyIQ’s research team will discuss the what the FDA still has on its plate in 2024.

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