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regulatory

CDRH Releases New Dataset for Biocompatibility of Medical Devices

CDRH Releases New Dataset for Biocompatibility of Medical Devices     On April 16, the FDA’s Center for Devices and Radiological Health (CDRH) released a new public dataset designed to assist chemistry labs in ensuring the robustness of chemical characterization methods used to assess the biocompatibility of medical devices. In a statement from Jeff Shuren, M.D., …

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FDA Medical Device Sterilization Town Hall Series Continues April 29

FDA Medical Device Sterilization Town Hall Series Continues April 29     As part of its efforts to work with the medical device community on device sterilization alternatives in light of new EPA standards for ethylene oxide (EtO) emissions, the FDA is hosting a virtual town hall on April 29, 2024, from 1:00pm-2:00pm ET. The town …

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Federal Court Enters Consent Decree Against Philips Respironics Following Recall of CPAP Machines

Federal Court Enters Consent Decree Against Philips Respironics Following Recall of CPAP Machines     On April 9, the U.S. District Court for the Western District of Pennsylvania entered a consent decree of permanent injunction against Philips RS North America (“Philips Respironics”), Respironics California, Philips Holding USA, and Roy Jakobs, CEO of Royal Philips, along with …

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IoT: The Next Big Thing in Precision Lab Equipment

IoT: The Next Big Thing in Precision Lab Equipment     Precision is one of the most essential equipment qualities for consistency and authenticity in experimentation. The Internet of Things (IoT) promises to enhance the accuracy of the health and pharmaceutical sectors while integrating smaller, more user-friendly devices. Thanks to its many advantages, IoT is poised …

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From Concept to Market: The Strategic Journey from IND to NDA

From Concept to Market: The Strategic Journey from IND to NDA     Drug discovery and development is a complex, multifaceted process that can be challenging to navigate. The primary goal is to ensure that new therapies are safe and effective for patient use. The process includes several critical stages, each governed by strict regulatory oversight …

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FDA Proposes Ban on Electrical Stimulation Devices

FDA Proposes Ban on Electrical Stimulation Devices     The FDA has proposed to ban electrical stimulation devices (ESDs) intended for self-injurious or aggressive behavior due to unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated through new or updated device labeling. This is the second time the FDA has proposed …

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FDA Outlines its Approach to Artificial Intelligence Regulation

FDA Outlines its Approach to Artificial Intelligence Regulation     U.S. regulation of artificial intelligence (AI) in medical devices will involve cooperative work among multiple departments within the FDA. On March 15, the FDA released “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together,” which outlines how the agency’s medical product …

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EPA Issues Final Rule on Ethylene Oxide Emissions

EPA Issues Final Rule on Ethylene Oxide Emissions     On March 14, the U.S. Environmental Protection Agency (EPA) announced its final rule on ethylene oxide (EtO) emissions. The rule is intended to reduce lifetime cancer risks for people living near commercial sterilization facilities. The EPA estimates that implementation of the new regulations will reduce EtO …

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FDA Issues New Draft Guidance on Premarket Cybersecurity Considerations

FDA Issues New Draft Guidance on Premarket Cybersecurity Considerations     On March 12, the FDA issued the draft guidance “Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act.” Which includes select updates to the FDA guidance document “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (aka, Premarket Cybersecurity …

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Enhancing Post-Market Surveillance: Strengthening Medical Device Regulation in the UK

Enhancing Post-Market Surveillance: Strengthening Medical Device Regulation in the UK     The UK’s medical device and in-vitro diagnostic device regulation is undergoing significant changes to enhance post-market surveillance (PMS) requirements. The MHRA (Medicines and Healthcare Products Regulatory Agency) conducted a consultation, which received responses supporting the need for more transparent and risk-proportionate PMS requirements. Consequently, the …

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