Category Archives: start-up

Joy of 510(k) Clearance

Cinco de Mayo was a good day--for many reasons! One of the reasons is that I received notification from FDA that a 510(k) we submitted for our startup medical device client received clearance. Did I mention "5" is my number? 510(k) clearance on 5/5--pretty sweet! The project has been rewarding and challenging, as with most medical device product development projects. I especially found the FDA 510(k) review process to be a bit more challenging than I had expected. A few rounds of "refuse to accept" followed by a reviewer who seemed to challenge just about everything we provided as supporting evidence. Having gone through this experience with a tough and difficult reviewer is something I do appreciate. Working with him actually made the second submission much more complete and smoother (so far) with FDA. Receiving...

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...

Medical Device Perfection – Is It Possible?

Medical device perfection is a matter of perspective. And ensuring your product development team has similar point of view and perspective for your medical device is very important. I think it starts with the vision of the device. It also pertains to what you are trying to achieve and when you are trying to achieve it. Perfection. Probably not a good choice of words. I'll try to explain through a short story based on a current medical device product development project. We are in the midst of a electronic medical device. Without getting into too many specifics, the device is class II. It has a custom designed PCB with embedded firmware (along with a few other electronic components). The electronics are contained within a custom designed enclosure. The device mates with single-use disposable components....

Mad Rush to FDA

Now that the U.S. Federal Government is back in business, will there be a mad rush for medical device companies to send submissions, such as 510(k)s, to FDA? Did the two week shutdown create a backlog at FDA? Have companies been waiting on this day? What about all those submissions that were already in the queue prior to October 1? I can report that since the shutdown, I have been in communication with FDA on a 510(k) submission. Keep in mind the user fees associated with this were paid prior to shutdown. It's been encouraging to know that FDA seems to be active reviewing submissions during the past couple weeks. I can always admit that the shutdown was a little bit of a blessing of sorts too. We have been working on...