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

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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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The Underrated Variable of IoMT Device Security: Collaboration

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The Underrated Variable of IoMT Device Security: Collaboration     Healthcare delivery organizations face significant operational risks (at best) and dangerous patient outcomes (at worst) if they fail to sufficiently secure internet-connected devices and equipment across their entire lifecycles. To put some rather eye-opening numbers to it: a recent Ponemon Institute survey revealed that more than …

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The Underrated Variable of IoMT Device Security: Collaboration

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The Underrated Variable of IoMT Device Security: Collaboration     Healthcare delivery organizations face significant operational risks (at best) and dangerous patient outcomes (at worst) if they fail to sufficiently secure internet-connected devices and equipment across their entire lifecycles. To put some rather eye-opening numbers to it: a recent Ponemon Institute survey revealed that more than …

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Advancing Digital Health: Huma SaMD Platform Gains U.S. Clearance

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Advancing Digital Health: Huma SaMD Platform Gains U.S. Clearance     This week Huma Therapeutics received 510(k) clearance for its configurable Software as a Medical Device (SaMD) disease management platform, which previously received Class IIb approval in the EU. The FDA Class II clearance allows users to add AI algorithms to the disease-agnostic platform, potentially speeding …

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Automating Computer Systems Validation for Your QMS

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Automating Computer Systems Validation for Your QMS      Companies must show that their software systems are performing as expected to comply with regulatory requirements. All validation activities and test results must be documented to define both how the software is used and what the user needs to do with it. By using this documentation, we …

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Medical Technology and ESG: Solving the Data Problem

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Medical Technology and ESG: Solving the Data Problem     In a recent State of ESG In Manufacturing survey, just one third (31%) of respondents reported high confidence in the quality and accuracy of their organization’s supply chain data. That lack of confidence is a harbinger of risks to come, as low confidence in data means …

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What You Need To Know About FDA Remote Medical Device Inspections

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What You Need To Know About FDA Remote Medical Device Inspections     Back in 2021, I wrote that FDA should have the authority to inspect medical device facilities remotely. This would allow FDA to check these facilities when in‑person inspections weren’t possible. The remote inspection argument was especially compelling in the throes of Covid-19, which …

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FDA To Host Webinar on Electromagnetic Compatibility of In Vitro Diagnostic Devices

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FDA To Host Webinar on Electromagnetic Compatibility of In Vitro Diagnostic Devices     The FDA is hosting a webinar on February 2 from 1:00-2:00pm ET for interested stakeholders to discuss the final guidance Electromagnetic Compatibility (EMC) of Medical Devices and its applicability to in vitro diagnostic (IVD) devices. The FDA announced that during this webinar it …

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FDA Issues Final Guidance on “Device” and “Counterfeit Device” Definitions

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FDA Issues Final Guidance on “Device” and “Counterfeit Device” Definitions     The FDA has issued the final guidance: Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents.  The guidance is intended to clarify the FDA’s approach for referencing the terms “device” and “counterfeit device” …

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Preparing for a Data-first Regulatory World

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Preparing for a Data-first Regulatory World     Even in today’s eCTD world, most life sciences regulatory teams still think and work in terms of documents, paragraphs and sentences when putting together collateral for marketing authorization and variations submissions. Yet it is data, rather than pre-prepared dossiers, that are moving into central focus now. Stakeholders across …

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