Publications

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...

Insights

FDA issues final orders classifying radiological image analyzers and related software
Registered Content

On 22 January 2020 the U.S. Food and Drug Administration (FDA or the agency) published three regulations formally classifying certain radiological image analyzers and related software,...

News

Medical device advertising claims referred to FTC and FDA by National Advertising Division

On 11 December 2019, the National Advertising Division (NAD) announced that it has referred advertising claims made by a medical device company to the Federal Trade Commission (FTC) and...

Analysis

International Products Law Review 2019: Issue 75
Registered Content

We are excited to bring you the latest issue of our International Products Law Review with insights and updates on all aspects of products law. In this issue, we explore the trustworthiness ...

News

New draft guidance proposes a shift in how the FDA will evaluate certain device modifications

On September 28, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a draft guidance document, entitled "The Special 510(k) Program," which, when finalized,...

News

FDA’s new decision tree for medical device PMAs and De Novos accompanies final uncertainty guidance

On 30 August 2019 the U.S. Food and Drug Administration (FDA or the agency) issued a final guidance document entitled "Consideration of Uncertainty in Making Benefit-Risk...

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

De Novo requests: FDA releases updated RTA checklist

On 9 September 2019, the U.S. Food and Drug Administration (FDA or the agency) issued its final guidance document entitled "Acceptance Review for De Novo Classification Requests."

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