A Predicate Device in the context of a 510(k) submission refers to a legally marketed medical device in the United States that is used as a reference or comparison when seeking clearance from the U.S. Food and Drug Administration (FDA) for a medical device. When a manufacturer wants to introduce a new medical device to […]
At #8C, we wanted to start a new initiative of creating a š¬šš«š¢šš¬ šØš š ššš¬, dealing with medical devices and its regulations. In that effort, here is the ššššš ššØšø. Hope you like these #titbits of information. Here is #FAQ01 on holding š¦š®š„šš¢š©š„š š¢š¦š©šØš«š š„š¢ššš§š¬šš¬
The Gazette Notification, released on 18th Jan 2022, gave a provision for #Registration_Listings, for newly regulated Medical Devices
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