Unpacking Averages: The Difference Between Data and the Truth: Comparing FDA’s UDI Database with FDA’s 510(k) Database
Health Law Advisor
DECEMBER 6, 2022
To do that, I needed to create two different lists of 510(k) submissions, one for all submissions that include the word “software” in the 510(k) summary, and then one for all medical devices in the 510(k) process designated as a combination product. Using software in connection with drugs is a relatively new product category.
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