Industry Update – Guidance Document published by FDA for Small Entities

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Small Entity Compliance Guide – Guidance Document published by FDA FDA published a final rule in the Federal Register entitled “Medical Devices; Laboratory Developed Tests” (“LDT Final Rule”), amending FDA regulations to make explicit that in vitro diagnostic products (IVDs)… 

Industry Update – QMSR for Medical Devices

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Quality Management System Regulation (QMSR) for Medical Devices The Quality Management System Regulation (QMSR) for Medical Devices, released by the FDA on January 31, 2024, is a significant update to the existing Quality System (QS) regulation (21 CFR Part 820).… 

Cybersecurity in Medical Devices

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FDA requires medical devices be secured against cyberattacks Medical devices are increasingly connected to the Internet, hospital networks, and other medical devices to provide features that improve health care and increase the ability of health care providers to treat patients.…