News & Analysis as of

Medical Testing CLIA

Arnall Golden Gregory LLP

Applying For or Updating a CLIA Waiver During The Pandemic

While much of the COVID-19 testing has been done by government and private dedicated laboratories, many providers in the acute and long-term care space are moving towards providing their own CLIA-waived tests.  ...more

ArentFox Schiff

Big Changes in FDA’s Serology/Antibody Testing Requirements

ArentFox Schiff on

On May 4, 2020, the FDA issued new Guidance that drastically changes the requirements for serology/antibody tests for the COVID-19 epidemic. The Agency did this by updating (and superseding) previous February 29, and March...more

Bass, Berry & Sims PLC

Thinking of Using Serology Testing for COVID-19? Don’t Overlook CLIA Certification Rules

Bass, Berry & Sims PLC on

With the spread of COVID-19, healthcare providers—including those that are more easily accessible to patients, like primary care practices and urgent care clinics—are looking for fast and reliable tests to diagnose infection....more

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