Check out Medtech Insight's US FDA Warning Letter Data Tracker here.
Warning Letters – September 2024
The US Food and Drug Administration released three warning letters last month, two of which went to Chinese device testing labs accused of improper treatment of laboratory animals.
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As the EU Life Sciences Strategy aims to drive innovation, the medtech sector is pushing for a pivotal role in a mission intended to embrace green and digital transitions, address regulatory obstacles and reduce dependency on external sources.
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The FDA's final LDT ruling was struck down in federal court last month. For now, diagnostic companies can commercialize under CLIA regulations or apply for FDA approval. McDermott and Tribun Health have shared insights on the risks, pros and cons of both regulatory routes.
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Ireland’s NSAI reinstated under IVD Regulation designation list
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The preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection.
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The FDA's final LDT ruling was struck down in federal court last month. For now, diagnostic companies can commercialize under CLIA regulations or apply for FDA approval. McDermott and Tribun Health have shared insights on the risks, pros and cons of both regulatory routes.
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The Republic of Ireland’s record in life sciences is impressive. Decades of investment, education and training have been major winners for the country’s successful economy. But its success is drawing unwanted attention from the US. Trump wants “to have that.”
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Mechanisms in the draft treaty that the more than 190 member states of the World Health Organization have finally agreed to are expected to “materially affect companies,” particularly those that develop, manufacture or distribute pandemic-related health care products.