Subject: 510K pre-market notification Контекст следующий: класс II медицинского оборудования по FDA:-510K pre-market notification -биосовместимость конкретных применяемых материалов |
О вреде аббревиатур - это или 510 градусов Кельвина (237 градусов Цельсия) или 510 тысяч. |
Статья /номер/ 510К Закона о пищевых продуктах, лекарственных препаратах и косметических средствах Section 510(k) of the Food, Drug and Cosmetic Act requires those device manufacturers who must register to notify FDA, at least 90 days in advance, of their intent to market a medical device. This is known as Premarket Notification - also called PMN or 510(k) . It allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, "new" devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified. Specifically, medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. Such change or modification could relate to the design, material, chemical composition, energy source, manufacturing process, or intended use. |
Shu, гениально!!! |
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