May 15, 2008

510(k) response received

A while back we received our 510(k) response, about 60 days after the submission, and if a 10 was as good as could reasonably be expected we ended up with a solid 8, so we're all pretty happy. We had one hardware comment, a couple labeling comments, around six software comments and a couple non-software V&V testing comments. Nothing actually that hard to respond to or that left us scratching our heads, "How do we do that!?". If we kept key parts within the company we could probably respond in the 30 days given.

I'm trying to think of something useful I could pass on, but most of it boils down to little things we forgot to include in the submission even though they are clearly documented on the FDA website. The FDA obviously spent a lot of time reading the Software V&V and requested some more typical condition testing instead of the worse case testing that we focused on. Everything they requested was very reasonable though. Same with the non-software V&V testing, out of the 20 or so reports the FDA only commented on two, I missed a standard and tested to the wrong limit, and for one test they wanted more typical condition testing. They probably can't use the words "brilliantly done" in the letter, but they did use the phrase "generally acceptable" which is good enough I think.

Anyway, it is good to receive a response and now we have something to focus on. We'll get the work done ASAP and hopefully the next letter we get from the FDA is an approval.

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