ACLA Files Suit over FDA’s LDT Final Rule
The ACLA and HealthTrackRx sued the FDA, arguing that the agency’s new LDT rule improperly classifies lab testing services as medical devices.
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Search Results for: compliance
Some Patients Repeat Fecal Tests to Delay Colonoscopy
A new study found that 7.4% of patients repeated fecal testing rather than proceeding directly to colonoscopy as guidelines recommend.
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Senator Rand Paul Introduces Resolution to Repeal FDA’s LDT Final Rule
Senator Rand Paul announced a resolution to repeal the FDA’s LDT Final Rule, arguing it oversteps authority and threatens medical innovation.
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How Greening Your Lab Can Boost Your Bottom Line
Green initiatives can go a long ways to cut waste and positively impact the bottom line for clinical laboratories.
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FDA Issues Warning Against Using Cue Health COVID Tests
The FDA warned against using Cue Health’s COVID tests due to modifications that reduced test reliability and increased risk of false results.
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