Development of FDA-Regulated Medical Products

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This is an excerpt from Elaine Whitmore's book, Development of FDA-Regulated Medical Products. Chapter One discusses the changing face of healthcare in the United States. The book in its entirety includes a review of the significant changes within the FDA that affect the requirements and review of medical products; updated facts and figures; expansion of subjects that have grown more critical, such as clinical outcomes, human factors, and marketing objectives; and additional new topics such as the role of product development in hazard analysis, recalls, and product liability.

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