Tag Archives: FDA 510(k)

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....

Medical Device Product Development in 12 Months

Can it be done? I guess before you answer, it might be helpful for me to share a few more details.
  • Device is pretty clearly a class II with dozens of potential predicates.
  • This is essentially a "me too" product.
  • The project seems to be well-funded.
  • Product development has been outsourced to firms with expertise.
So do you think this medical device can be brought to market in 12 months time? I believe so. Granted there isn't much wiggle room in the schedule. And of course, there will be a FDA 510(k) submission involved. But getting this product ready for launch in a year seems feasible. We had the project kickoff on November 26, 2012 and really got started the first part of December. So far, we have finished the planning phase, including definition of...