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GMP News

FDA Warning Letter Statistics on Medical Devices in the past Fiscal Year

On behalf of the ECA Concept Heidelberg regularly analyses the deficiencies in FDA Warning Letters regarding medical devices. Since medical devices can be part of a combination product consisting of a medicinal product and a medical device, these statistics are also of interest to manufacturers of these products. What did the FDA criticise in the last fiscal year?

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Artificial Intelligence in Medical Devices - Notified Bodies' Point of View

In November 2024, the "Team NB" published a 28-page guideline in the style of a questionnaire on the topic of "Artificial Intelligence in Medical Devices".

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New FDA Guidance on Risk Analyses for Drugs, Biologics and Combination Products

Last year, the FDA issued a draft guidance on the risk assessment of medicinal products, biologics and combination products. The guideline has a total of 13 pages, divided into five chapters, a glossary and a sample table. It is therefore relatively straightforward. What is it about?

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