Medical Innovation Exchange

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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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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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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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MHRA Announces New UK Approved Bodies

MHRA Announces New UK Approved Bodies     The Medicines and Healthcare products Regulatory Agency (MHRA) has designated two new UK Approved Bodies, LNE-GMED UK and Scarlet NB UK. They join the seven current UK Approved Bodies, increasing capacity for the certification of medical devices in the UK. LNE-GMED UK has been designated as a UK …

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CDRH Releases List of Proposed 2024 Guidance Documents

CDRH Releases List of Proposed 2024 Guidance Documents     Change control plans for AI/ML, remanufacturing of devices and medical device shortages are among the guidances the FDA Center for Devices and Radiological Health (CDRH) is prioritizing in 2024. On October 10, CDRH published a list of guidance documents it intends to publish in the coming …

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Final Guidance for Submission of Off-The-Shelf Software in Medical Devices

Final Guidance for Submission of Off-The-Shelf Software in Medical Devices     On August 11, the FDA released the Final Guidance Off-the-Shelf Software Use in Medical Devices. The document, which supersedes Off-The-Shelf Software Use in Medical Devices issued September 27, 2019, provides information on recommended documentation sponsors should include in a premarket submission for FDA’s evaluation …

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Managing Software Vulnerabilities: How to Utilize ISA/IEC 62443 and Software Bills of Materials

Managing Software Vulnerabilities: How to Utilize ISA/IEC 62443 and Software Bills of Materials     In recent years, more and more medical device manufacturers (MDMs) have come to rely on software bill of materials, or SBOMs. Some do this to help track licensing while others do so as part of a product vulnerability management process. In …

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Automating Computer Systems Validation for Your QMS

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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Regulatory Intelligence: Meeting the Demands of Today’s Global Regulatory Market

Regulatory Intelligence: Meeting the Demands of Today’s Global Regulatory Market     The increase in global regulatory demands for medical devices has presented new challenges for regulatory affairs and intelligence teams. On May 16-17, The MedTech Regulatory Intelligence Summit will bring together regulatory professionals, device developers and regulators to look at current trends in FDA and …

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Regulating Point of Care Printed Devices

Regulating Point of Care Printed Devices     The use of 3D printing for medical devices opens tremendous opportunities in health care. It allows users to test and adjust components more quickly than traditional manufacturing and enables the creation of personalized products, such as custom prosthetics. However, questions remain about what oversight the FDA will have …

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