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Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, the Trump administration is reviewing candidates for FDA commissioner, the agency is trying to repair relations with the rare disease community, and Vanda will have an opportunity to defend its jet lag drug at a public hearing next month.

The US Food and Drug Administration has updated its draft guidance on how the drug and medical device makers should communicate with payors and other stakeholders about their products. The updates are intended to reflect provisions in the 2023 Consolidated Appropriations Act.

A recent survey published by Team-NB reveals that the growth of certificates for the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) slowed in 2025 compared to previous years. Additionally, the staffing levels for notified bodies (NB) have decreased due to a reduction in workload.

LISBON – A panel of experts at RAPS Euro Convergence 2026 discussed how artificial intelligence (AI) is being applied throughout the product lifecycle, from compiling premarket application submissions to assisting in the conduct of conformity assessments.

President Donald Trump on Tuesday confirmed that Marty Makary, Commissioner of the US Food and Drug Administration (FDA), is leaving the agency. He also announced on Truth Social that Kyle Diamantas, who currently serves as FDA deputy commissioner for food, will step up as acting FDA commissioner.

The European Commission on Tuesday published an implementing regulation that outlines uniform quality management and procedural requirements for conformity assessment activities conducted by notified bodies under the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR).

The healthcare product landscape in Europe is undergoing significant transformation—from multiple legislative overhauls to the rapid adoption of artificial intelligence (AI) and other boundary-pushing technologies. For regulatory professionals attending RAPS Euro Convergence 2026 in Lisbon, the meeting is an opportunity to lean into community to stay on top of the myriad changes coming their way.

Key changes with the QMSR include a greater focus on risk management, a culture of quality, and lifecycle integration. One of the biggest changes, officials said, is that risk is at the center of quality processes