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Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.

Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.

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News

FDA updates FAQ on COVID-19 tests and validation

Last week, on 23-25 June 2020, the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) updated the responses to six of the Frequently Asked Questions...

News

FDA’s revised COVID-19 test kit policy requires EUAs for serology tests

On May 4, 2020, the U.S. Food and Drug Administration (FDA)updated its policy on COVID-19 test kits, which was originally published on March 16, 2020. In particular, the revised...

News

Senate bill proposes laboratory developed tests to be regulated under CLIA process

U.S. Senator Rand Paul introduced legislation that would place laboratory developed testing procedures within the Clinical Laboratory Improvement Amendments (CLIA) process and assess the...

Insights

Diagnostics regulation reform proposals move forward again with an updated VALID Act
Registered Content

The updated, bipartisan Verifying Accurate, Leading-edge IVCT Development Act (VALID Act), creates a regulatory framework for a new product paradigm called in vitro clinical tests (IVCTs),...

News

FDA issues expanded testing policy for novel coronavirus to address public health emergency

On Saturday, 29 February 2020, the U.S. Food and Drug Administration (FDA) issued an “immediately in effect guidance” to swiftly expand testing for the novel coronavirus...

News

Genetic tests and medication response: FDA announces collaborative review of scientific evidence

FDA announced the introduction of a collaboration between the Center for Devices and Radiological Health (CDRH) and Center for Drug Evaluation and Research (CDER) to provide the...

News

Clarifying clinical decision support: FDA overhauls guidance to focus on risk

On 27 September 2019 the U.S. Food and Drug Administration (FDA or the agency) released the draft guidance entitled "Clinical Decision Support Software" (CDS guidance), which...

News

Final guidance provides additional clarity to the Humanitarian Device Exemption program

On 6 September 2019 the U.S. Food and Drug Administration (FDA or the agency) issued its final guidance document entitled "Humanitarian Device Exemption (HDE) Program." The...

News

FDA resumes enforcement relating to laboratory developed tests

On April 4, 2019, the U.S. Food and Drug Administration's (FDA or the agency) Office of In Vitro Diagnostics and Radiological Health issued a Warning Letter to Inova Genomics Laboratory ...

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