Alexander Gaffney from raps.org released an interesting article on FDA’s completion of the rewrite of device pre-submission guidance. FDA issued a guidance document to outline the changes and why these meetings are so important. They believe that the meetings offer a way to identify, clarify, and solve any obvious potential issues before the process starts. Also contained in the guidance are appendices that are associated with specific types of applications. To read the full guidance click here. To read the full article click here.
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