Senior Director of ML Strategies Aaron L. Josephson and Mintz Associate Benjamin M. Zegarelli will be featured speakers at the Regulatory Affairs Professionals Society (RAPS) 2019 Regulatory Convergence conference held from September 21-24 in Philadelphia.
Mr. Josephson will serve as a session leader and Mr. Zegarelli will serve as a speaker for a panel discussion on Monday, September 23 titled “US FDA's Proposed Paradigm for Digital Health Oversight.” Additional speakers include Marisa Cruz, Senior Medical Advisor for Digital Health at the U.S. Food and Drug Administration (FDA), and Michael Zagorski, Director of Quality and Regulatory Compliance for ImPACT Applications, Inc.
The session will explore how the FDA's proposed Digital Health Software Precertification Program would impose a new regulatory structure on a significant sector of the device ecosystem. Speakers will discuss the current status and content of the FDA's proposal and describe the FDA's current thinking about software regulation so that regulatory professionals can be prepared for the new model, including understanding how the new model differs from the existing regulatory paradigm for traditional (hardware) medical devices.
Mr. Josephson advises clients on health care policy issues related to medical devices and other FDA-regulated commodities. Prior to joining ML Strategies, he spent 10 years with the FDA, most recently as a senior policy advisor in the Center for Devices and Radiological Health where he led legislative policy development activities related to all aspects of medical device regulation and oversight.
Mr. Zegarelli counsels clients on compliance and regulatory issues, with a focus on FDA regulations. He advises clients in the pharmaceutical, medical device, and biotech industries, and provides counsel on the federal and state laws surrounding manufacturer product development, marketing, and post-market regulatory compliance.
View the full conference agenda and additional details here.
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