FDA’s new draft guidance on the agency’s Breakthrough Device Program gets into a lot of detail. The FDA sets out how it wants to work closely, very closely, with device developers to bring new technologies to market.
If you have ever gone through a presubmission interaction, you will know that these days the agency likes to chat – and to share documents and kick things around with you. This draft guidance makes it clear they want more of the same. FDA proposes:
- Sharing copies of documents to provide feedback by email exchange of redline edits.
- “Sprint Discussion” with 7 day cycles of questions, answers and feedback
- Expedited review by queue jumping for designated Breakthrough Technologies.
Of course much depends on if the device really is a breakthrough – and we have asked before about the nature of innovation. True breakthroughs are indeed wonderful things, but the reality of device innovation is that it’s more often a process of iterative development building on the work of countless others who have gone before.
One thing is clear, FDA isn’t lowering the bar. Requirements for breakthrough Devices stay the same and the agency points out that reviews may take longer than normal because of the new technologies involved, but not as long as would be the case if FDA wasn’t sprinting to help.
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