I would like to get some kind of baseline answer to the perennial question, "How long is it going to take" for the compilation of a 510(k).
- By "some kind of," I don't mean a single figure, but at least a range, perhaps along with some information about what variables can have a significant impact on the amount of time it takes.
- By "compilation," I mean just the time it took to put one together, not time spent researching the device, intended use, regulations, guidances, standards, etc, nor time spent going back and forth with team members to get additional information, clarifications, and explanations, nor time spent trying to determine whether the information that has been provided is adequate to support clearance.
I think no one really knows exactly how much time they spend on this type of project, because there are typically too many interruptions, detours, etc, to keep track of every minute. The ideal situation would be for someone fully knowledgeable about the device, intended use, regulations, guidances, standards, etc, to receive a neat package containing all of the information needed for the 510(k), and then be able to work uninterrupted from start to finish. Since that never happens (does it?), I’m assuming the best anyone can provide is a reasonably good guesstimate, not a hard figure.
So:
What is your (guesstimated) fastest ever 510(k) compilation time (in hours worked, not in calendar time)?
It would also be helpful to know whether you compiled your fastest 510(k) ever as an employee or consultant, for a start-up, large established company, or a mid-size manufacturer, and the general therapeutic area of the device’s intended use.
Any thoughts on WHY it went so quickly would also be of interest.
Thanks in advance for sharing your experience here in the RAPS Forum!
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com------------------------------