Conducting Effective FDA Pre-Sub Meetings: Tell, Don’t Ask… Lead, Don’t Follow!

For medical device companies, ineffective communication with FDA often leads to time-consuming and costly delays. Manufacturers may assume a classification or regulatory pathway for a new device – only to learn later that FDA disagrees. Unfortunately, most of these delays are completely avoidable!

For medical device companies, ineffective communication with FDA often leads to time-consuming and costly delays. Manufacturers may assume a classification or regulatory pathway for a new device – only to learn later that FDA disagrees. Unfortunately, most of these delays are completely avoidable! 

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