Insights Center

MedTechDive reported that the U.S. Food and Drug Administration is not yet ready to go to Congress to seek new powers for its evolving precertification pilot for software, but it will need new authorities to determine how the experimental path fits into the current regulatory scheme. The article included commentary from Senior Director of ML Strategies Aaron Josephson and Mintz Associate Benjamin Zegarelli.

An article published by Inside Health Policy quoted Aaron Josephson, Senior Director at ML Strategies, extensively in response to recent debate surrounding the U.S. Food and Drug Administration’s proposed rule “Reporting Information Regarding Falsification of Data,” which was previously withdrawn.