WebApr 8, 2024 · In 2024, the United States Food and Drug Administration (FDA) established the Breakthrough Devices Program (BDP), which allows for fast-tracking the approval of certain novel devices or device-led combination products (products that are therapeutic and/or diagnostic that combine drugs, devices, or biological products.) The goal of this … WebJul 24, 2024 · The image above represents chemical breakthrough time. To compute for chemical breakthrough time, two essential parameters are needed and these parameters are Thickness (l) and Diffusion Coefficient (D). The formula for calculating chemical breakthrough time: t b = l² / 6D. Where: t b = Chemical Breakthrough Time. l = Thickness.

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