Medical Innovation Exchange

FDA guidance

510k Submission Planning

510k Submission Planning     With an aim to provide thoughtful insight on how to go about planning a 510(k) submission long before the writing begins, we have created this helpful list of top tips, where we will outline the items you should be aware of when planning your 510K submission. Tip #1: Visit the FDA …

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FDA Updates Guidance on ISO 10993-1 for Evaluation of Biocompatibility  

FDA Updates Guidance on ISO 10993-1 for Evaluation of Biocompatibility       The FDA has updated its guidance, Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process,” to provide further clarification and updated information on the use of International Standard ISO 10993-1, …

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Decoding FDA Guidance on Decentralized Trials

Decoding FDA Guidance on Decentralized Trials     Last month the FDA released its draft guidance on the use of decentralized clinical trials (DCTs) for drug and device development. We spoke with Chris Fourment, MD, Senior Vice President of Clinical Strategy at Iterative Health, who specializes in structuring clinical trial programs, about the new guidance. He …

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