Insights Center

In this Q&A published by Legaltech News, Vice President of ML Strategies Christian Fjeld—former lead Democratic Senate staffer tasked with shepherding the American Vision for Safer Transportation through Advancement of Revolutionary Technologies Act (AV START Act) through the Senate—discussed why Congress failed to pass the AV START Act, how autonomous vehicles’ complexity isn’t lawmakers’ largest hurdle, and why the data privacy debate may factor into the next autonomous vehicle bill.

Warren, Cassidy To FDA: How Will You Identify Device Remanufacturers?

October 23, 2019 | Inside Health Policy

An article published by Inside Health Policy quoted Aaron Josephson, Senior Director at ML Strategies, on Senators Elizabeth Warren (D-Mass.) and Bill Cassidy (R-La.) letter to U.S. Food and Drug Administration (FDA), requesting information about the FDA's upcoming guidance clarifying the distinction between remanufacturers and servicers.

To Pitch Pre-Cert to Congress, FDA Builds a Case First

September 26, 2019 | MedTechDive

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.

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2019

FDA Update – In Conjunction with ASQ – New England Biomedical Discussion Group & RAPS

860 Winter St, Waltham, MA 02451

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