Обзор законодательства Управления по контролю за качеством пищевых продуктов и медикаментов (FDA) в отношении медицинского оборудования и взаимодействия с современными медицинскими практиками.

Аннотация

Since the emergence of medical devices, legislation has been developed to allow the Federal Drug Administration (FDA) to oversee their development, marketing, and usage. This paper discusses the history of the FDA's involvement in medical devices, current approval processes, and several case examples. Additionally, it discusses both short- and long-term effects with unexpected consequences to U.S. health care delivery.