FDA Labeling Requirements for Medical Devices
MA Lin-rong ZHEN Hui Zhejiang Certification Centre for Drugs (Hangzhou 310012)
Analysis the importance of the labeling for medical devices, introduce the Labeling regulatory requirements for medical device of FDA. including the general deice labeling and the specifically labeling requirements for In Vitro diagnostic products, investigational device, 510(K). GMP. and radiation emitting device.