All recent data points I have observed suggests so. Admittedly, helping clients navigate through FDA related issues has become a huge part of CQ’s business. But in my opinion, some of these cases and observations border a little on the edge of being egregiousness and excessive. Here are some examples:
- Very small medical device company inspected by FDA. Company has been making low-risk, 510(k) cleared device since late 1970s. FDA issued several page warning letter, with primary concern that company was marketing a device without proper FDA clearance. Company demonstrated otherwise.
- FDA requests sterilization residual data. Test data proves overwhelmingly and objectively that there are no residual concerns. Despite the data, FDA is still concerned.
- FDA decides to inspect company that manufactures low-risk class I devices. 483 observations are issued.
I wish I could go into much more detail in each case. If there is a trend I’ve noticed, it seems to be this: All FDA-registered companies need to be ready for a FDA inspection at any time. I would not have predicted FDA to show up with a few of my recent clients, but they did. It seems as though the days when FDA spends the majority of their time and resources only inspecting the “Big Boys” and for cause cases are gone.
Is this the FDA we as patients and consumers want? Do we want FDA inspecting manufacturers of low-risk products which have no history of issues? I don’t know. As a potential patient, I definitely want some assurance that the medical devices which could be used on me are as safe as possible.
Have you have any recent experiences with FDA you’d like to share?