Focuses on food and drug law and health care reimbursement and regulatory issues.
Served in prominent roles at the Food and Drug Administration (FDA) and on the Senate Health, Education, Labor and Pensions (HELP) Committee.
Advises manufacturers and developers of medical devices and diagnostics, drugs and biologics, and other industry participants regulated by the FDA, as well as hospitals and other providers.

Drawing upon his diverse health care industry and governmental experience, Nathan provides his clients with strategic, practical advice on cutting-edge regulatory, compliance and policy matters. He has worked extensively in the FDA regulatory field and also on coverage and reimbursement matters. Nathan also represents clients on due diligence and regulatory issues related to corporate transactions. His varied knowledge allows him to make connections across disciplines and take a multifaceted, creative approach to advising clients.

Innovative health care technology and delivery systems are rapidly transforming the sector, giving rise to new payment, regulatory and enforcement approaches. Nathan helps sophisticated clients prepare for these developments and, when necessary, influence them. He is sought after for his understanding and insights into the regulation of and payment for innovative approaches to health care, such as medical software, advanced diagnostics and pharmaceutical supply chain solutions. Nathan speaks and writes frequently about FDA policy developments and regulatory issues surrounding digital health and other topics.

Nathan works with clients in a broad range of highly regulated areas and issues, including:

Medical devices and diagnostics
Medical software and digital health
Pharmaceuticals
Hospitals, health systems and health care networks
Medicaid, Medicare and health care access
Medical products supply chain.

Representative Work

For multiple companies, assisted in obtaining favorable regulatory treatment of novel software-based interventions, including de novo clearances and developing marketing and compliance strategies to support product commercialization.
Assisted a client in developing a comprehensive global compliance policy relating to product quality and manufacturing, advertising and marketing, price reporting and supply chain considerations.
Represented outsourcing facilities in regulatory and compliance issues relating to implementation of the Drug Quality and Security Act of 2013, which he, while working for the Senate HELP Committee, helped negotiate and draft.
Represented a leading medical technology trade association in user fee negotiations with the FDA and in developing policy reforms for medical devices in the 21st Century Cures Act of 2016 and the FDA Reauthorization Act of 2017.
Advised a premier academic medical center in relation to the first de novo clearance obtained by a provider for a next-generation sequencing (NGS) oncology test.

"He is very knowledgeable, extremely practical and results-oriented, and has an exemplary ability to explain legal and regulatory issues to a wide variety of audiences."

Chambers USA, 2021

Education
J.D., Harvard Law School, 1999
B.S., University of Maryland, College Park, 1996
B.A., University of Maryland, College Park, 1995

Bar Admissions
District of Columbia

Recognitions

Chambers USA, Healthcare: Pharmaceutical/Medical Products Regulatory, 2019-2024.
The Legal 500 US, Healthcare: Life Sciences, 2024.

Affiliations and Public Service

Associate Chief Counsel, FDA, 2010-2012
Senior Counsel, Office of the Associate Commissioner for Regulatory Affairs, FDA, 2012-2013
Counsel, Senate Committee on Health, Education, Labor and Pensions, 2013-2014
Member, Food and Drug Law Journal Editorial Advisory Board, 2018-present

Speeches and Publications

Speaker, "Decoding FDA’s New Rule on LDTs: Insights, Implications, and Legislative Considerations," Food & Drug Law Institute, May 9, 2024.
Panelist, “The Growing Impact of International Trade Laws for Med Tech Companies,” MDMA Webinar, March 20, 2024.
Co-chair, “The New Normal: Navigating Post Pandemic Inspections,” 18th Annual FDA Inspections vSummit, November 8, 2023.
Speaker, “Diagnostics Reform — by Rule or Statute: Implications for Investment, Innovation and Commercialization,” The MedTech Conference, Anaheim, CA, October 9, 2023.
Co-chair, “PLI’s Life Sciences 2023: Navigating Legal Challenges in Drug and Device Industries,” New York, NY, September 14, 2023.
Moderator, “Digital Health Policy and Privacy Roundtable,” Food and Drug Law Institute’s Current Developments in Digital Health Technology and Regulation Conference, Webinar, November 30, 2022.
Moderator, “Diagnostics Reform at a Crossroads: Navigating Through a Pivotal Time,” The MedTech Conference, Boston, MA, October 26, 2022.
Co-chairperson and presenter, “FDA Reform: What to Expect With FDASLA,” PLI’s Life Sciences 2022: Navigating Legal Challenges in Drug and Device Industries, New York, NY, September 28, 2022.
Moderator, “Artificial Intelligence and Machine Learning: Product Development, Regulation and FDA’s Action Plan,” Food and Drug Law Institute’s Digital Health Technology and Regulation Conference, Webinar, November 10, 2021.
Co-chairperson and presenter, “Transitioning from the Public Health Emergency: Key Legal Issues and Lessons,” PLI’s Life Sciences 2020: Navigating Legal Challenges in Drug and Device Industries, Webinar, October 5, 2021.
Moderator, “Preparing Your Company for Diagnostics Reform and the VALID Act: Key Issues and the Road Ahead,” The Medtech Conference, Washington, D.C., September 27, 2021.
Speaker, “Navigating Your Life Science Legal Career in 2021 and Beyond,” Food and Drug Law Institute, Webinar, September 21, 2021.
Speaker, “The PREP Act: Understanding Its Role, Scope, and Limitations During a Public Health Emergency,” American Health Law Association’s Virtual Academic Medical Centers and Teaching Hospitals Institute 2021, Webinar, January 26, 2021?.
“Is IVD Reform Coming Soon? What it Means for You,” Virtual MedTech Conference, October 2020.
Speaker, “GCs & CLOs in Crisis: management and handling the aftermath of a crisis,” Webinar, ACC, September 30, 2020.
Presenter, “Is IVD Reform Coming Soon?,” Webinar, The MedTech Conference, September 14, 2020.
“The Evolving Regulatory and Commercial Environment for Digital Health and AI,” Academic Medical Centers and Teaching Hospitals Institute Conference, Arlington, VA, January 30, 2020.
“FDA’s New Approaches to Software Regulation: Pre-Certification and Artificial Intelligence,” AdvaMed MedTech Conference, Boston, MA, September 24, 2019.
“FDA: Fireside Chat: Grappling with AI Regulation,” Digital MedTech Conference, San Francisco, CA, May 22, 2019.
“Issues and Updates in Combination Products Regulation,” FDLI’s Annual Conference: Exploring Advanced Topics in Food and Drug Law, Washington, D.C., May 3, 2019.
“Federal Health Community Forum Session – FDA Digital Health Software Pre-Certification Program,” HIMSS19 Global Conference Education Program, Orlando, FL, February 12, 2019.
“Digital Health – What Lawyers Need to Know,” PLI’s Life Sciences 2018: Navigating Legal Challenges in the Drug and Device Industries, New York, NY, November 16, 2018.
“Inspection Evolution: FDARA, Program Alignment and Beyond,” The MedTech Conference, Philadelphia, PA, September 25, 2018.
“The Future of Medicine: Rethinking Our Approach to Digital Diagnostics,” Digital MedTech Conference, San Francisco, CA, April 25, 2018.
“New Medical Device Requirements and Where Manufacturers Should focus: MDUFA, FDARA and 21st Century Cures,” FDLI webinar, February 9, 2018.
“Key Developments for Medical Device Inspections in the United States and Around the Globe: Are You Prepared?” Medical Device Manufacturers Association (MDMA) webinar, MDMA, January 24, 2018.
“Digital Health Combination Products: What’s Next?” and “21st Century Cures Act and Beyond: Implications for Digital Health,” DIA Combination Products Conference, North Bethesda, MD, October 25, 2017.
Co-chair, PLI’s Life Sciences 2017: Navigating Legal Challenges in the Drug and Device Industries, New York, NY, October 5, 2017.