Federal Court Rules that Some Imaging Agents Must be Classified as Medical Devices, Not Drugs

In case you missed it: in Genus Med. Techs., LLC v. FDA, 2021, Federal court rules that some imaging agents must be classified as medical devices, not drugs.

Recently, the FDA lost its bid in federal court to retain the discretion to classify some imaging agents as drugs, even when they meet the definition of a device. This ruling has provoked continuing objections from both pharma and medical device industry players, as companies would be faced with the challenges to switch from drug good manufacturing practices (GMPs) to the quality systems regulations that apply to medical devices.

What do you think? Join the conversation online.

Criterion Edge Can Support Your Transition to Compliance

Reach out to Criterion Edge for support to get your technical documents of existing devices ready for MDR transition. Or get your new devices MDR compliant. We have expert medical writers to support your organizations in developing the necessary documents to ensure a smooth transition and meet these fast-moving deadlines. Get a free consultation today.

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In this blog, we share our insights and experiences to help companies build quality, scalability, and flexibility into their regulatory writing.  We hope you find it insightful. For questions, please contact info@criterionedge.com.

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