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Developing an Effective and Sustainable Regulatory Strategy for Today’s Global Market

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Developing an Effective and Sustainable Regulatory Strategy for Today’s Global Market     Global regulatory demands for medical devices are increasing substantially, and regulatory teams are faced with the pressure of increased workloads and the need for more resources. To help regulatory professionals identify strategies and best practices in developing an effective and sustainable regulatory strategy …

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Regulating Point of Care Printed Devices

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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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FDA Seeks Industry Collaboration on Medical Device Active Surveillance System

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FDA Seeks Industry Collaboration on Medical Device Active Surveillance System     The FDA is seeking input from organizations interested in collaborating with the agency on the development and execution of the medical device active surveillance system. “Once realized, such a system will optimize data collection, quality, completeness, and analysis within a comprehensive framework to assess …

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MedTech Developers Can Improve Surgical Workflows Through Thoughtful Innovation

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MedTech Developers Can Improve Surgical Workflows Through Thoughtful Innovation     A surgeon’s workflow inside of the operating room, combined with their workload, has been studied widely but still stands to be better understood. A surgical workflow is an established pattern of processes that a surgeon repeatedly performs that minimize the potential occurrence for mistakes and …

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PRI Establishes Working Group to Improve Medical Device Quality and Supply Chain Resiliency

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PRI Establishes Working Group to Improve Medical Device Quality and Supply Chain Resiliency     The Performance Review Institute (PRI) has convened a new working group comprised of representatives from the medical device industry, government, and industry associations to identify and recommend best practices to improve medical device quality and enhance supply chain resiliency. The purpose …

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FDA Issues Final Guidance on Surveying, Leveling, and Alignment Laser Products

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FDA Issues Final Guidance on Surveying, Leveling, and Alignment Laser Products     On January 30, the FDA issued its final guidance on Surveying, Leveling, and Alignment (SLA) Laser Products for manufacturers of laser products. The final guidance outlines the FDA’s approach on the applicability of the FDA’s performance standard regulations to surveying, leveling, and alignment (SLA) …

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Ethical Considerations for Children in Clinical Investigations: FDA Publishes New Draft Guidance

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Ethical Considerations for Children in Clinical Investigations: FDA Publishes New Draft Guidance     The FDA has published a new draft guidance that outlines its current views regarding ethical considerations for clinical investigations of medical products in children. The guidance seeks to balance the need to obtain data on the safety and effectiveness of drugs, biological …

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