This article provides a snapshot of the synthetic biology market in a number of key industries and explores how disruptive technologies can significantly alter the way businesses operate across any market space.
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While clinical data is required for manufacturers of high risk devices and implants, the vast majority of manufacturers that make low-to-medium risk devices may not need to conduct clinical trials for their products or produce peer-reviewed literature that supports their clinical use. This article helps identify the specific clauses of the guidance document that pertain to clinical data and explores alternative pathways to compliance.