Basil Knowledge Center
What’s New at CDRH? A Different View.
Are you ever curious about what parts of our industry keep CRDH busy?
Or which medical disciplines are most active these days?
At Basil, we believe these kinds of trends and insights are important. The Life Science industry needs to know how our government agency spends its time and energy. Unfortunately, it’s impossible to get such trends from the FDA itself. And unless you want to start doing numerous repetitive web searches, manually collect individual results, and compile them all into a summary — a frightfully tedious proposition — there’s no reasonable way to get this data yourself.
But if you had all the FDA data at your fingertips, in a modern database that makes search queries incredibly easy… well then, it’s a piece of cake. This is what Basil Systems does.
For example, there were 731 510(k)s that gained positive decisions by CDRH in the last 3 months. Here is a snapshot of the cleared 510(k) and De Novo applications in the past 30, 60, and 90 days, by review panel. Who’d have guessed that the General Hospital category was the most active? The high level of activity in Orthopedics isn’t surprising, but I expected to see more in Cardiovascular.
Perhaps my intuition about Cardiovascular is skewed by the fact that there’s so much work done in that space, but mostly through PMAs. So let’s see the same chart for recent PMA activity. For this we included not just original PMA applications (which are relatively infrequent), but also all supplements that were cleared by the FDA. Behold, Cardiovascular activity is off-the-charts compared to all other categories.
How does this compare to your experience or expectations?
This is a simple example of the unique insights Basil Systems can deliver, because we’re the only service with the FDA’s entire dataset in a single cutting-edge SaaS platform.
I’ll work on sharing other interesting healthcare insights and trends enabled by our platform. If you want to learn more, or have a particular question or insight you’d like to see.