The global In-Vitro Diagnostics (IVDs) Medical Device Market was valued at approximately USD 86 billion in 2024 and is projected to reach USD 135 billion by 2034, growing at a CAGR of 4.8% over the ...

On 29 April, the US Food and Drug Administration (FDA) published its Final Rule, making explicit that laboratory-developed tests (LDTs), defined as in vitro diagnostics (IVD) products, are medical ...

In vitro diagnostic (IVD) devices for the detection of the Bacillus species were assigned to class II on Friday, following the release of a US Food and Drug Administration (FDA) final rule. The IVDs ...

This course provides a basic overview of IVDs, including an historical background focused on regulatory requirements. It introduces key regulations and guidelines necessary for effective product ...

In vitro diagnostics (IVDs) are a mainstay of modern medicine. People of all ages and their healthcare providers rely on these tests to determine the risk of a wide range of chronic and acute diseases ...

The value of data to the in vitro diagnostics industry has never been more apparent. At every corner of the healthcare industry, data is being used to help doctors make the best treatment decisions ...

The final rule amends FDA regulations to make it explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer of the IVD is a laboratory. The final ...

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In 2013, FDA Commissioner Margaret Hamburg announced that the agency was looking to establish a risk-based framework for regulating lab-developed tests (LDTs) and released a draft guidance document to ...

New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has issued draft standard protocols for issuing licenses of TB In-Vitro Diagnostics (IVDs) devices, based on their performance and ...