Areta Kupchyk

Foley Hoag LLP

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Latest Posts › Clinical Laboratory Testing

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FDA Publishes Long-Awaited In Vitro Diagnostics Proposed Rule – Medical Device Regulations Would Apply to Laboratory Developed...

FDA published a proposed rule that would regulate IVDs, including LDTs, as medical devices, drastically altering the regulatory landscape for LDTs. The proposed rule would update the definition of IVDs in 21 CFR § 809.3 to...more

10/3/2023 / CDRH , Clinical Laboratory Testing , Comment Period , Food and Drug Administration (FDA) , Healthcare , Manufacturers , Medical Devices , Proposed Rules , Regulatory Requirements

FDA Issues Safety Communication About Genetic Non-Invasive Prenatal Screening Tests

Last week, the Food and Drug Administration (FDA) issued a safety communication warning the public about the potential risks of false results with genetic non-invasive prenatal screening tests (referred to as “NIPS” or...more

4/26/2022 / Clinical Laboratory Testing , Diagnostic Tests , Enforcement , Food and Drug Administration (FDA) , Genetic Testing , Pregnancy , Screening Procedures

FDA Develops Program to Expedite COVID-19 Drug Review

In response to the public health threat of the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) has formed a special emergency program to expedite development of COVID-19 therapies – the Coronavirus Treatment...more

4/8/2020 / Clinical Laboratory Testing , Coronavirus/COVID-19 , Emergency Management Plans , Food and Drug Administration (FDA) , Health and Safety , Infectious Diseases

FDA Will Facilitate Biological Product Development Against COVID-19

The U.S. Food and Drug Administration (FDA) announced in a March 27, 2020 letter to industry that the Center for Biologics Evaluation and Research (CBER) has implemented new measures to prioritize biological product...more

4/6/2020 / Clinical Laboratory Testing , Coronavirus/COVID-19 , Food and Drug Administration (FDA) , Health and Safety , Infectious Diseases , Life Sciences

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