Mon.May 06, 2024

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Can a Device Be Found Not Substantially Equivalent Because of Cybersecurity Risks? A Review of FDA’s Draft Guidance on Cybersecurity in Medical Devices

FDA Law Blog

By Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — FDA recently issued a draft guidance which would update the agency’s Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions guidance. The draft guidance provides recommendations on what is required to meet cybersecurity obligations under section 524B of the Food, Drug and Cosmetic Act (FD&C).

Medical 105
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Medical Music Mondays: Simple Febrile Seizures

PEMBlog

Simple febrile seizures are scary for parents – but all that is really needed is reassurance and education. Lyrics Febrile seizures, you’re warm and you’re shaking Not like a teen who’s convulsing and faking The fever spikes, unconscious and stiff tonic and clonic it’s over in a jiff Simple febrile seizures they may seem scary, Parents are trembling worried and wary they’re self limited and stop on their own all you need is reassurance and discharge home This

Medical 52
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Deborah Meyersen

Vascular Physician

Everyone in the office provided stellar care!? They're all very caring yet professionals. They're excellent in what they do. I'm so excited to have found someone who is actually able to provide help for my legs.