Posts in Medical Devices.
Blogs
Clock 9 minute read

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 ...

Blogs
Clock 9 minute read

Introduction

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 ...

Blogs
Clock 9 minute read

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 ...

Search This Blog

Blog Editors

Recent Updates

Related Services

Topics

Archives

Jump to Page

Subscribe

Sign up to receive an email notification when new Health Law Advisor posts are published:

Privacy Preference Center

When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. This information might be about you, your preferences or your device and is mostly used to make the site work as you expect it to. The information does not usually directly identify you, but it can give you a more personalized web experience. Because we respect your right to privacy, you can choose not to allow some types of cookies. Click on the different category headings to find out more and change our default settings. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer.

Strictly Necessary Cookies

These cookies are necessary for the website to function and cannot be switched off in our systems. They are usually only set in response to actions made by you which amount to a request for services, such as setting your privacy preferences, logging in or filling in forms. You can set your browser to block or alert you about these cookies, but some parts of the site will not then work. These cookies do not store any personally identifiable information.

Performance Cookies

These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. They help us to know which pages are the most and least popular and see how visitors move around the site. All information these cookies collect is aggregated and therefore anonymous. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance.