Free Market Report: New FDA "Q-Sub" Guidance Document: Pre-Submission Program and FDA meetings

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In February 2014, FDA published the following final guidance document, applicable to manufacturers of both Class II and Class III devices: Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff. This important document applies to those companies who seek feedback from FDA before or after applications are sent to FDA for new or modified devices. Because the FDA definition of medical device includes in-vitro diagnostics (IVDs), stand-alone software, accessories, mobile medical applications (apps), etc. then this document will affect a wide variety of companies in France.

Author: Ken Block, RAC, President, Ken Block Consulting

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