Tag Archives: FDA 510(k)

510(k) Submission – 3 Things I’ve Learned

As you are probably aware, a 510(k) submission is required in order to get FDA market clearance for nearly all class II devices. A few days ago, I received notification from FDA that a 510(k) submission I prepared has received market clearance. This is the second 510(k) clearance we have received this year. The two 510(k) submissions involved different medical device product types. The first was for a single-use, disposable device. The second 510(k) was for a electro-mechanical device that included embedded firmware. Each 510(k) submission resulted in quite a bit of learning that will be applied to future submissions. And fortunately, we were able to learn a great deal from the single-use device and apply it towards the more complicated, electro-mechanical product. Here are three things I've learned about the FDA...

Mixed Emotions About FDA

I've shared some recent trials and tribulations on current medical device product development projects and FDA submissions. The saga continues. Last week, I received a round of questions from FDA on a 510(k). Yes, we made it through the RTA phase and into the substantiative review. Some of the questions were familiar themes from this submission, having already fielded FDA questions on the same topics during RTA stage of review. As I read the questions, I was more than a little frustrated and agitated. I felt as though the evidence provided, teleconferences with FDA, and email correspondence suggested that what was provided would meet FDA expectations. I thought wrong. A couple of the topics seemed to be somewhat time consuming to address. Project timeline out the window! And as...

Delivering Bad News: 510(k) Submission Will Be Late

The past couple months have been a whirlwind, pushing to get a medical device product ready for a 510(k) submission by mid June. Yes, we have an aggressive timeline. And yes, just like any other product development project, we have had our share of unexpected issues. All in all, we were still moving toward mid June. That is until last week. One of the critical components is a silicone molded part. We received first articles last week and all looks great. However, we only received a handful. And we need to do some destructive testing to support the FDA 510(k) submission. When I found out this news, the target submission date was about 3 weeks away. Learning this, though, will likely push our submission back about 2 - 3 weeks. Sucks! I instantly started...

Medical Device Accelerator in Memphis, TN

The medical device industry has several geographic pockets. Memphis, TN is one of these, especially in orthopedics. I recently read about this medical device accelerator located in Memphis called ZeroTo510. They seem to have all the key pieces for a medical device concept to get off the starting blocks. Part incubator, part educator, part investor, part mentor. The program is geared towards helping medical device inventors and entrepreneurs get to a FDA 510(k) submission, while providing guidance and direction along the way While I have no idea how successful this program has been, the model is very intriguing. So much so that I wonder if something like this could be piloted in central Indiana....