How has the FDA's and the medical products industry's use of guidance documents evolved over the years and how will the use of guidance documents continue to evolve in the future?
Brown, Christopher Matthew
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Due to the extremely wide range of medical products being governed by the same few sets of general regulations, the FDA has created a system of documents to guide and direct manufacturers on how to apply those regulations to specific types of products. How those documents are used and how effective they are at providing adequate guidance was determined through a series of phone interviews with FDA and medical products industry personnel. In general, the guidance document system works well for both the industry and the FDA. However, some improvement is desired in the process for creating and revising guidance documents due to the long, multiple-stage process currently in place.
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