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FDA’s New Draft Guidance on 510(k) Implant Devices: What You Need to Know

FDA Law

airport security screening), or surgical procedures, as well as the potential for reoperation or revision of the implant. We find that this information is noteworthy for manufacturers to consider. For instance, FDA highlights risks associated with everyday activities (e.g., programming, monitoring, maintenance).

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Aging and Climate Change: Karl Pillemer, Leslie Wharton, & Ruth McDermott-Levy

GeriPal

And so any additional stressor such as heat or an extreme weather event or having to move from your home because of a climate related disaster can really tax an older adult whose window of resilience is more limited. Ruth: That’s not prevention, that’s screening. I mean, you are talking about a huge, huge network.

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MedTech Conference Download

FDA Law

Below, we provide a snapshot of the three-day event: Update on the International Medical Device Regulators Forum (IMDRF). It’s an easy way to manage the transition.”. In closing, he advised manufacturers who plan to market their products beyond the public health emergency to plan to submit marketing applications. CDRH Town Hall.