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On the ECA Academy website you have all the important information for your daily work in the GMP/GDP environment directly at hand: current news, suitable online training, eLearning offers, conferences, seminars and courses, a comprehensive guideline database and many other services. Should you not find what you need, just contact us by phone at +49 (0)6221 / 84 44 0 or send an e-mail to info@gmp-compliance.org.

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GMP News

FDA Warning Letter Statistics on Medical Devices in the Past Fiscal Year 2025

On behalf of the ECA Concept Heidelberg regularly evaluates 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 (there are other combination options in the USA), these statistics are also of interest to manufacturers of these products. What do the statistics for 2025 look like?

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FDA Breakthrough Device Program

The FDA has published current success figures as statistics for its "Breakthrough Devices Program". What is the current status?

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US President Trump extends Transition Period for EtO Sterilisation

Sterilisation with ethylene oxide (EtO) is widely used in the medical device sector, although the technology is controversial for environmental reasons. An extraordinary measure has been taken in the US to achieve an extension of the status quo for medical device sterilisation companies.

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