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 I received the FDA questions, I was putting the finishing touches on a complimentary submission. A second submission that had direct ties and linkage to the content of the first. As I took a break from compiling the second submission to read 510(k) questions, I immediately put the breaks on. Based on FDA comments, there was no point in sending the second 510(k) until the questions were answered. Second project timeline be damned too!
Did I say frustrating?
But at the same time, as a potential consumer and recipient of medical device technologies, reading the level of depth and detail of the FDA 510(k) questions was also encouraging. The types of data and information expected is a little bit remarkable and definitely thorough. More thorough than just about any other 510(k) submission I’ve read or been a part of. As a consumer, I felt that FDA is doing the proper due diligence to ensure new devices introduced in the U.S. are as safe and effective as possible.
I immediately shared the list of questions with the medical device startup. It was a Friday, and not exactly the news any of us wanted going into a weekend. But as the startup CEO lamented, FDA establishes the rules for medical device companies. There is little we can do except to react and adjust. And that’s just what we are doing.