FDA Watch: CDRH Budget May Not See Steep Cuts in FY 2026
A leaked budget document for the next fiscal year suggested non-user fee funding may be up slightly compared to recent years.
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Next Steps: With LDT Final Rule Now Null, Industry Groups Urge Lab Managers and Pathologists to Advocate for Change
CAP and AMP officials weigh in on plans to push for a legislative- or CLIA-based approach to future LDT oversight
LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
FDA’s LDT Oversight Framework Could Impact 60,000+ Tests
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FDA’s 2016 Guidance Plans Include LDTs and Other Diagnostics Topics
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FDA Workshop Addresses Security of Medical Devices
From - G2 Compliance Advisor
The U.S. Food and Drug Administration (FDA) is joining the cadre of government agencies calling attention to the cybersecurity risks of wireless, internet-and network-connected devices and…
FDA and CMS Address LDT Regulation Before Energy and Commerce Committee
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FDA Details Oversight of Medical Applications On Smart Phones and Tablets
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Final FDA Guidance on RUO, IUO Products Raises Compliance Concerns for Labs
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