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Regulatory Requirements › Risk Management › Clinical Laboratory Testing

Mintz - Health Care Viewpoints

FDA’s Backup LDT Enforcement Method: Specimen Collection Kits

Mintz - Health Care Viewpoints on

We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority to regulate laboratory developed tests (LDTs) as medical devices and to phase...more

Robinson & Cole LLP

COVID-19 Testing — Additional Considerations

Robinson & Cole LLP on

At the start of the COVID-19 pandemic, each state and the federal government announced various states of public health emergencies which enabled them to suspend or modify various laws, rules, and regulations to accommodate...more

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