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@5555academy From what we have been told I believe the device would fall under a Class II. The device is a day procedure with little to no risk. This would qualify it for 510 (k) https://t.co/br2sVs2Psr
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Drugs, Devices, and the FDA: Part 1: An Overview of Approval Processes for Drugs https://t.co/wJnYVSnwBJ Drugs, Devices, and the FDA: Part 2: An Overview of Approval Processes: FDA Approval of Medical Devices https://t.co/M589ieJiZL