Diagnostics industry companies, patient groups, [BB1]and trade associations are speaking up in the wake of last week’s news that US Food and Drug Administration user fee reauthorization legislation – which Congress must pass soon to maintain agency operations – might not include long-discussed diagnostic regulatory reforms.
Health Industry Groups Press For Diagnostics Reform Bill
Almost 50 stakeholder groups have signed onto a letter to US Congressional leadership that asks lawmakers to pass the VALID Act, which would update the country’s approach to diagnostic test regulation. Congress needs to pass a user fee package this month to ensure full FDA funding.
More from Legislation
AdvaMed’s top priorities for the 119th Congress include modernizing US Medicare services and expanding patients’ access to the latest medical technologies.
• By
A federal judge in Texas delivered what is most likely a fatal blow to the US FDA’s final rule, which would have regulated lab-developed tests as medical devices.
• By
President Trump’s CDC director nominee was pulled after vaccine positions appeared too extreme for some Republicans, but the nominations to lead the FDA and NIH advanced to the Senate floor despite last-minute drama.
• By
Democrats are raising concerns that the continuing resolution intended to fund the government for the remainder of fiscal year 2025 gives Trump too much power, though it is unclear whether the FDA would be as impacted as other agencies.
More from Policy & Regulation
• By
Cybersecurity, sustainability and regulatory intelligence all need factoring into risk management today as AI and data availability change the goalposts. Eight experts tell Medtech Insight how compliance efforts must adapt.
• By
About 3,500 full-time FDA employees are expected to be laid off as part of a restructuring of the Health and Human Services Department. Experts questioned whether the cuts could be implemented without harming FDA’s core mission.
• By
The IVD industry’s new 10-point plan for healthcare change shows that medtechs will keep calling the German government to account. Tariffs, sector resilience, digital functionality are among the pressing issues industry wants answers to.