Posts in Medical Devices.
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This post was co-authored by David Schwartz, CEO and Co-Founder at Ethics Through Analytics, and Michael Shumpert, Data Science Executive at Mosaic Data Science.

As you may know, we have been submitting FOIA requests asking FDA to share data from its various programs.  In October, FDA granted[1] our April FOIA request in which we asked the agency to add back demographic data fields that it had previously removed from its public Medical Device Report (“MDRs”) databases. To find potential bias, we encourage manufacturers to use this data to look for any disproportionate impact its ...

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Frequently, I am asked by clients to predict how long it will take for FDA to review and clear a 510(k).  At a high level, I observe that on average clearance can take 160 days according to the data.  Then, beyond that, I observe that review times are highly variable among differing product codes, and the very first Unpacking Averages post I wrote in October 2021 provided a graphic to show just how much variation there was depending on the technology.  Here, though, I want to dive into yet another separate factor that should be taken into account, the seasonality of FDA ...

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Those who have been reading this blog know that I like to analyze collections of documents at FDA to discern, using natural language processing, whether, for example, the agency takes more time to address certain topics than others. This month, continuing the analysis I started in my October post regarding device-related citizens petitions, I used topic modeling on the citizens petitions to see which topics are most frequent, and whether there are significant differences in the amount of time it takes for FDA to make a decision based on the topic.

Discerning the Topics

As you probably ...

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