Tag Archives: 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...

Class I Medical Device Should have a DHF

If you are developing a class I medical device, you could make a solid argument for not documenting Design Controls and not maintaining a Design History File (DHF). In fact, your argument would be supported directly by FDA Design Control regulations. Very few class I devices even require Design Controls per FDA. However, if this is the approach you decided to take, I would advise against this. You might argue that documenting Design Controls will only slow you down on your process to bring your class I device to the market. Perhaps. So why do I recommend documenting Design Controls and maintaining a DHF for your class I medical device? Design Controls are documented, objective evidence that the product development process has been followed. Design Controls help ensure that User Needs are translated...

greenlight.guru Helps Ensure Medical Device Design Control Compliance

You might have read about some of our adventures with greenlight.guru. Today, I'd like to share another chapter in this startup journey. We had a call with a potential investor / resource. The guy had 20+ years experience in the medical device industry. The purpose of the call was to share a little more about greenlight.guru and do a brief product walk through. As we did so, the guy had strong energy about him. Every time we would offer an opinion, comment, or share details about the software, it felt as though he was bringing bad juju and negativity. Going into the call, I had good energy and an open mind. Right after the call, I felt like someone ran over my dog and slashed my tires. Now that there has...

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...