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The Food and Drug Administration Reauthorization Act (FDARA), recently signed into law, includes the Medical Device User Fee Amendments of 2017 (“MDUFA IV”). This new law affects multiple aspects of the device review process. MDUFA IV supplements FDA’s funding of device regulation, with the goal of increasing the speed and efficiency of the Agency’s review of new devices, as well as improving the safety and effectiveness of marketed devices. In addition to modifying the user fees, MDUFA IV broadens the scope of submission subject to user fees and performance goals. Webinar panelists will discuss relevant aspects of FDARA and the MDUFA IV Commitment Letter, highlight major changes to the program, and discuss the effects on the device industry, including the issuance of substantive key new guidance documents, such as when new 510(k)s must be submitted.

Nathan Brown, Partner, Akin Gump Strauss Hauer & Feld LLP
Sandra Cohen Kalter, Vice President and Chief Regulatory Counsel, Medtronic, and Member, FDLI Board of Directors
Aaron Josephson, Policy Advisor, CDRH, FDA

Moderated by Jeffrey N. Gibbs, Director, Hyman, Phelps & McNamara, PC, and Member, FDLI Board of Directors

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Speaker Biographies

NATHAN A. BROWN is a partner in the health care and life sciences practice at Akin Gump, who focuses on food and drug law and health care reimbursement and regulatory issues.  Mr. Brown advises health industry participants with regard to medical devices, drugs and biologics, as well as cosmetics and food products regulated by the U.S. Food and Drug Administration (FDA). He also advises providers, including academic medical centers and hospital systems, on Medicare and Medicaid reimbursement issues. His practice covers regulatory, compliance and policy advice.  Prior to joining the firm, Mr. Brown served in several prominent roles with the FDA. As an FDA detailee, he served as health policy advisor to the Senate Health, Education, Labor and Pensions (HELP) Committee. On behalf of HELP Committee Chairman Tom Harkin (D-IA), Mr. Brown played a lead role in negotiating and drafting the Drug Quality and Security Act of 2013 (drug compounding and track and trace legislation), and in coordinating passage of the Animal Drug User Fee Act of 2003 (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA) reauthorizations. He advised committee leadership on a broad range of FDA-related legislative and oversight matters, including device, drug and biologics issues, and met with stakeholders across the FDA-regulated industries.

SANDRA COHEN KALTER is Vice President and Chief Regulatory Counsel at Medtronic, where she leads a team of legal regulatory experts in various areas of government regulation, including FDA law, import and export trade laws, environmental health and safety, advertising, promotion and social media.  Ms. Kalter serves as Co-Chair of AdvaMed’s Advertising and Promotion Working Group and is a member of AdvaMed’s Legal Committee and AdvaMed’s Case for Quality Working Group.  Prior to joining Medtronic, she practiced FDA law with King & Spalding for 13 years, with an emphasis on medical devices. Before joining King & Spalding, Ms. Kalter practiced law at Weil, Gotshal & Manges in Washington, DC, specializing in food and drug law, advertising and consumer product safety. She received her BS in journalism from Northwestern University’s Medill School and her JD from The National Law Center of George Washington University. Ms. Kalter is a member of the District of Columbia Bar and the American Bar Association.

AARON JOSEPHSON is a senior policy advisor at FDA’s Center for Devices and Radiological Health (CDRH) where he works on projects involving regulatory policy, strategic planning, communications, and budget. He was the primary CDRH representative in discussions with Congress and industry about the 21st Century Cures Act and the Food and Drug Administration Reauthorization Act (FDARA). He also served on the FDA team that negotiated the reauthorization of the medical device user fee program (MDUFA 4). Prior to joining CDRH, Aaron worked at FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). Aaron has a BA in Political Science from the University of Virginia and a MS in Regulatory Science from Johns Hopkins University.

JEFFREY N. GIBBS is a Director in the law firm of Hyman, Phelps & McNamara, P.C. in Washington, DC. In this role, he advises companies on a wide range of issues, including product approvals, marketing, clinical studies, and enforcement. Prior to entering private practice, he was Associate Chief Counsel for Enforcement at the Food and Drug Administration (FDA). He has written extensively on FDA regulatory topics, and was previously Chair of the Editorial Advisory Board of the Food and Drug Law Journal. He is currently General Counsel of The Food and Drug Law Institute (FDLI) and a member of FDLI’s Board of Directors. He is also on the editorial advisory board of IVD Technology, and was a member of the Human Subjects Research Board for George Mason University. Mr. Gibbs is a graduate of Princeton University and New York University School of Law.

2017-11-29T12:12:14+00:00