Bradley Merrill Thompson

It is common for FDA and others to show a map of the United States with the states color-coded by intensity to showcase the total number of inspections done in that state.  Indeed, FDA includes such a map in its newly released dashboard for FDA inspections.  In reviewing that map with the U.S. map color-coded to reflect where medical device establishments are located, do you notice anything?  Not to destroy the suspense for you, but it turns out that FDA tends to inspect where medical device inspection facilities are located.  Really.

We wanted to get beneath those numbers in two ways.  First, it’s much more informative to look at the data at a county level because there’s actually quite a bit of variation county by county.  Second, and more importantly, we wanted to normalize the inspection data by the number of facilities.  In other words, by looking at inspections per facility, we can get a better sense of the inspection frequency in each county.


Continue Reading Unpacking Averages: Likelihood of FDA Medical Device Inspections

This month, we’re going to look at a visualization that uses network techniques. Visualizing a network is a matter of nodes and edges. If the network were Facebook, the nodes would be people, and the edges would be the relationships between those people. Instead of people, we are going to look at specific device functionalities as defined by the product codes. And instead of relationships, we are going to look at when device functionalities (i.e., product codes) are used together in a marketed device as evidenced by a 510(k) submission.

Continue Reading Unpacking Averages: Popular Ways to Combine Device Functionality

In this column, in the coming months we are going to dig into the data regarding FDA regulation of medical products, deeper than the averages that FDA publishes in connection with its user fee obligations.  For many averages, there’s a high degree of variability, and it’s important for industry to have a deeper understanding.  In

The application of artificial intelligence technologies to health care delivery, coding and population management may profoundly alter the manner in which clinicians and others interact with patients, and seek reimbursement. While on one hand, AI may promote better treatment decisions and streamline onerous coding and claims submission, there are risks associated with unintended bias that

At the January 8-9, 2015 FDA public meeting on the agency’s proposal to regulate a portion of lab developed tests (LDTs), there was much debate regarding whether FDA has jurisdiction over IVDs made at clinical laboratories. Not coincidentally, on January 7, the day before the meeting, the American Clinical Laboratory Association released a white paper developed for the Association by a couple of prominent constitutional law scholars.  The paper outlined the arguments at a high level against FDA jurisdiction over lab developed tests generally. But with all due respect to the authors as well as the speakers at the FDA public meeting, the discussion to date is taking place at such a high level that I do not find it particularly helpful. Mostly the discussions merely stake out the positions held by interested parties. They don’t advance the collective understanding of the issues.

In connection with the public meeting, I developed five questions which help me think through the legal issues. I’d like to share those questions, in an effort to drive the discussion to a more granular level where differences can be more effectively debated and resolved. In addition, as with any lawyer, I’m drawn to precedent, so I’d like to share how FDA has tackled similar issues before. At the end of this post, based on precedent but also my conclusion that both sides are overstating their legal positions, I offer a path forward down the middle-of-the-road.

5 Questions That Frame FDA Authority Over IVDs Made at Labs

In posing these questions, I start with the most basic and simple and then move closer and closer to the current facts. In each case, I’ll also give you what I think the answer is.


Continue Reading The LDT Debate: Understanding FDA’s Jurisdiction Over IVDs Made at a Clinical Lab