FDA Draft Documents - They Really DO Matter

I have seen this time and again. A medical device manufacturer follows the available FDA guidance documents, goes to the pre-submission meeting, presents their case, and leaves feeling that the meeting went well. Imagine the surprise three weeks later when the FDA sends a three-page letter advising the manufacturer to incorporate elements of the draft guidance document that the manufacturer did not even know existed. In this episode, I try to explain this concept to Joe Hage.