Parallel Fluidics’ Post

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🤿While microfluidics is a promising field, it lacks FDA-recognized standards, leaving microfluidic devices subject to the same rules as any other medical device. This ambiguity can create regulatory hurdles for product developers, specifically when it comes to sterilization validation. There are however voluntary consensus standards for development, validation, and routine control that are recognized by the FDA for medical devices.  Opting for an established sterilization method with a consensus standard can streamline your path to regulatory approval. 🚀 Click the link to learn more about the different sterilization methods available for microfluidic devices. https://lnkd.in/e7m-iHHg #Microfluidics #RegulatoryChallenges #FDAStandards

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