isExemptFromPremarketAuthorisation(是否免于上市许可)

Definition：Indicates whether the medical device is exempt from premarket regulations. For the FDA, Premarket approval (PMA) is the process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of class III devices. Therefore, these devices require a premarket approval (PMA) application under section 515 of the FD&C Act in order to obtain marketing clearance. Please note that some Class III preamendment devices may require a Class III 510(k).

定义：表示该医疗器械是否不受上市法规的约束。对美国FDA来说，上市许可(PMA)是评估III类医疗器械安全性和有效性的科学监管审查过程。III类器械是指那些支持或维持人类生命，对预防人类健康损害具有重大意义，或预防潜在的不合理患伤病风险的器械。 由于III类器械的相关风险水平，美国FDA已确定，仅通过一般和特殊控制不足以确保III类器械的安全性和有效性。因此，这些器械需要根据FD&C法案第515条申请上市许可(PMA)，以获得销售许可。请注意，一些III类合法上市器械可能需要进行III类510(k)申请。

类型：ATTRIBUTE（属性）

Cardinality（基数）：0..1

字符长度：1..80

数据类型：NonBinaryLogicEnumeration

BMS代码表ID：168

xPath：/catalogue_item_notification:catalogueItemNotificationMessage/transaction/documentCommand/catalogue_item_notification:catalogueItemNotification/catalogueItem/tradeItem/tradeItemInformation/extension/*[namespace-uri()=’urn:gs1:gdsn:medical_device_trade_item:xsd:3’ and local-name()=’medicalDeviceTradeItemModule’]/medicalDeviceInformation/isExemptFromPremarketAuthorisation