このエピソードについて
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three weeks later when the FDA sends a three-page letter advising the manufacturer to incorporate elements of the draft guidance document that the manufacturer did not even know existed.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.
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このポッドキャストの他のエピソード
MDR, MDD, nasal cannulas and the PIP patient safety breakdown - we covered it all at the southern California meeting of the Opthalmic World Leaders (OWL) group. Join me and Greg Kunst as we talk regulation, clinical validation testing and industrial-grade silicone.
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Michelle chats with MDG's Joe Hage about the fast-approaching May 2020 deadline for implementation of MDR, and a possible idea for extending the deadline. Remember "meaningful use" and the eight stages with targeted implementation dates for adoption of the electronic medical record (EMR)? &nbs…
Michelle and Greg talk the technology benefits of launching in Europe, the lack of assessment panelists and the challenges of translating MDR into multiple languages without losing (or changing!) the intention in this second installment from the presentation with the southern California OWL group.
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