Hi Anon,
You can have two submission open at the same time. It is best practice to let the reviewers know in both submissions that this will occur; however, you are only required to let them know in the second. I have tried to organize a telecon with both reviewers around day 50 to get both on the same page. It was agreed to once and declined the other time; however, it was useful when it occurred.
Best,
Mike
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Michael Nilo
Network Regulatory Partners
Portland OR
United States
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Original Message:
Sent: 08-May-2018 11:01
From: Anonymous Member
Subject: Overlapping 510ks
This message was posted by a user wishing to remain anonymous
We have a device that is able to perform two functions. The first intended use was cleared via a 510k, with one division within the FDA - and the second intended was cleared by de novo by a second division within the FDA. We have upcoming improvements to each - each of which is clearly within the purview of the respective division. It is our intention to submit the first 510k within the next few weeks. And then, our expectation is that the second 510k will be ready to submit sometime later this summer - likely before the other has been cleared.
Does anyone know if we will be able to have two 510ks open at the same time?
If anyone has experience with the multiple use devices it would be great to hear from you! Thanks.