In a recent announcement, the Food and Drug Administration (FDA) has identified a broad list of Class II medical devices that, when finalized, will be exempted from premarket notification requirements, subject to certain limitations per se. The FDA has published this notice in accordance with procedures established by the 21st Century Cures Act, and is now looking forward to public response in the form of comments.
Ahead of nearing mandatory eCTD deadline, 5/5/2017, to clear the confusion surrounded, the Food and Drug Administration (FDA) of United States has clarified what exactly it is looking for in the Type III Drug Master File (DMF) submissions. Before jumping straight into what exactly the Type III DMF refer to, let us discuss the DMF and the types in detail.
Drug Master Files & its Types