The FDA Reauthorization Act, which would reauthorize the MDUFA IV user-fee agreement and enact additional device regulatory reforms, passed the US House July 12 on a unanimous vote. Lawmakers applauded the bill's inclusion of device facility inspection reforms and an over-the-counter hearing aid provisions. The legislation now moves to the Senate, where a crowded legislative schedule could mean delayed consideration.
[Editors' note: Follow progress with legislation impacting the device and diagnostics industry with Medtech Insight's US Congress Tracker.]
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Now that a federal judge has ruled the US FDA exceeded its authority by unilaterally assuming regulatory oversight of lab-developed tests, what’s the agency’s next move? And does it really have one?
Medical devices, diagnostics, and equipment face tariffs announced by President Donald Trump, despite industry pleas for exemption. The tariffs, ranging from 10%-49%, impact most countries trading with the US, potentially hindering innovation and increasing costs in the medtech sector.
Energy and Commerce Health Subcommittee Democrats focus on criticizing HHS Secretary Kennedy’s RIF announcement, including 3,500 FDA jobs among cuts across HHS agencies. Representatives were left wondering if user fee programs would continue, even if reauthorized.
AdvaMed’s top priorities for the 119th Congress include modernizing US Medicare services and expanding patients’ access to the latest medical technologies.
The preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection.
Abbott and J&J reassured investors they will maintain their 2025 profit forecasts. Abbott projects $5.05 to $5.25 per share and plans a new $500m investment in manufacturing and R&D sites. J&J anticipates $400m in tariff-related costs but committed $55bn in US investment over four years.
Congress has launched an inquiry into 23andMe amid privacy concerns following its bankruptcy, particularly regarding the potential sale of sensitive user data. Additionally, a Cybernews report gave 40 DNA testing firms an average cybersecurity grade of D, citing widespread vulnerabilities and data breaches, along with inadequate public information about their security practices.
