Stephanie Philbin

Stephanie Philbin, a partner in the firm’s FDA practice and a member of its Life Sciences group, concentrates on Food and Drug Administration laws. She joined Goodwin in 2007.

Stephanie advises clients on regulatory and compliance issues including those related to clinical trials, pre-market submissions, including 510(k), de novo, and premarket approval applications, the Quality System Regulation, Medical Device Reporting, recalls, product importing and exporting, and product advertising and promotion. Stephanie assists clients in responding to agency inspections and investigations and in filing comments with FDA to respond to various regulatory initiatives. She reviews SEC filings of FDA-regulated companies and conducts due diligence of companies as part of mergers and acquisitions and initial public offerings. Stephanie also assists in litigation.

Stephanie is a member of the DC Bar Association. She previously served on the advisory board of Bloomberg Law Medical Devices Law & Industry Report.

Prior to joining Goodwin, Stephanie was counsel at Wilmer Cutler Pickering Hale and Dorr. Stephanie is a former instructor at Georgetown University Law Center’s Foundations for Foreign Lawyers.

In 2020, LMG named Stephanie a “Regulatory Star” for Medical Devices. While in law school, Stephanie served as the Articles Editor for the Georgetown Journal of Legal Ethics.

Stephanie frequently lectures on food and drug law. Most recently, in September 2022 (and previously March 2022), she co-presented on “Medical Devices, Combination Products, and Companion Diagnostics Boot Camp: A Review of FDA Guidelines and Regulations” at the American Conference Institute’s FDA Boot Camp. Her other speaking engagements include:

• Co-Presenter, “Product Development & Commercialization – Regulatory Fundamentals,” UCLA Biodesign Bootcamp, September 2022
• Co-Presenter, “Building a New Medical Device (or Evolving an Existing One) with Regulations in Mind,” MassMedic, July 2022
• Co-Presenter, “Analyzing Recent Changes to FDA Approval Processes and Future Implications on Product Liability Cases,” American Conference Institute’s 25th Annual Conference on Drug and Medical Device Litigation, December 2020
• Speaker, “Preparing for the Worst: Adverse Events Monitoring, Pharmacovigilance, Risk Management, and Recalls,” American Conference Institute’s FDA Boot Camp, March 2021 and September 2020
• Speaker, “Deep Learning Advances in MedTech: Unlocking Investment Opportunities,” Columbia Business School Alumni Club of New York, December 2019
• Speaker, “Law and Digital Health: Legal and Compliance Strategies and Implications,” scwish:pharma’s “New Rules, New Roles,” November 2019
• Speaker, “Post-Marketing Issues for Medical Device Companies,” Food and Drug Law Institute’s Introduction to Drug and Device Law and Regulation for Patient Organizations, November 2019
• Speaker, “Introduction to Medical Devices, Combination Products, Companion Diagnostics, and Medical Apps: A Review of FDA Guidelines and Regulations,” American Conference Institute’s FDA Boot Camp, September 2019
• Speaker, “Dealing with Adverse Events/Product Problems,” Food and Drug Law Institute/Center for Devices and Radiological Health In-House Training Course: Introduction to Medical Device Law and Regulation, June 2020, June 2019, October 2015, April 2015, and November 2014
• Speaker, “Post Marketing Issues,” Food and Drug Law Institute’s Introduction to US Medical Device Law and Regulation, April 2019, July 2018, and May 2014
• Speaker, “Overview of Reportable Malfunctions,” Q1 Productions’ 5th Annual Medical Device Postmarket Surveillance, January 2019
• Speaker, “The Regulation of Digital Health and Health IT,”  Canadian Consulate General’s Canadian Technology Accelerator, October 2018
• Presenter, “FDA Regulation of Digital Health and Health IT,” Wolters Kluwer’s Health Law Thought Leadership webinar, May 2018
• Speaker, “Premarket Notification 510(k)s and De Novo Applications,” Food and Drug Law Institute’s Introduction to US Medical Device Law and Regulation, April 2018
• Speaker, “Postmarket Surveillance and Remediation,” MedTech Intelligence Medical Device Cybersecurity Workshop, October 2017
• Speaker, “Regulations and Definitions,” MedTech Intelligence’s Medical Device Recalls, November 2016
• Speaker, “Medical Device Reporting,” American Conference Institute’s FDA Boot Camp: Devices Edition, July 2016
• Speaker, “Presenting Risk Information in Promotional Materials and Updated Good Reprint Practices,” AdvaMed’s Advertising and Promotion of Medical Devices Program, November 2014 and November 2013
• Speaker, “Fundamentals of FDA Regulatory Device Law” and “Comprehending the 510(k) Clearance Process,” American Conference Institute’s FDA Boot Camp Devices Edition, October 2012
• Presenter, “The Food and Drug Administration Safety and Innovation Act: The 2012 Device Amendments and Their Potential Effect,” Bloomberg BNA webinar, October 2012
• Speaker, “Off-Label Issues: Scientific Exchange and Unsolicited Requests,” AdvaMed 2012 MedTech Conference, October 2012
• Speaker, “Medical Devices: Classification and the Essentials of the Device Premarket Review Process,” American Conference Institute’s FDA Boot Camp, March 2012 and March 2010
• Speaker, “Enforcement and Compliance,” Food and Drug Law Institute’s Introduction to Medical Device Law and Regulation, March 2012 and March 2010
• Speaker, “Premarket Approval Application,” American Conference Institute's FDA Boot Camp Devices Edition, October 2011
• Presenter, “Changes to FDA’s 510(k) Program,” BNA webinar, May 2011
• Speaker, “Legal Considerations: Industry Use of Social Media,” MassMEDIC's program on Use of Social Media During Regulatory Uncertainty, May 2011
• Speaker, “The FDA, the Internet & Social Media: Regulatory Issues and Evolving Policy,” Medical Development Group, September 2010
• Speaker, “Post Marketing Issues" and "Quality System Regulation (QSR),” Food and Drug Law Institute’s Introduction to Medical Device Law and Regulation, January 2010
• Speaker, “Presenting Risk Information in Promotional Materials,” AdvaMed’s Medical Technology Learning Institute’s program on Advertising & Promotion of Medical Devices in an Age of DTC and Social Media Marketing, November 2009
• Speaker, “Post-Market Requirements and Concerns for Medical Devices,” American Conference Institute’s FDA Boot Camp, July 2007
• Speaker, “Device Postmarket Reporting in the Drug Safety Age,” AdvaMed, November 2006
• Speaker, “Preparing for and Responding to an FDA Inspection,” AdvaMed, May 2005
• Speaker, “Medical Device Technologies and the FDA: GMPs for Combination Products,” Virginia Biotechnology Summit, 2004 

Stephanie has co-authored numerous articles including:

• Co-Author, “Top 5 Compliance Issues for Medtech Firms Transitioning To Data-Enabled Solutions,” MedCity News, January 27, 2023
• Co-Author, “Top 5 FDA Considerations for Medtech-Enabled Data Platforms,” MedCity News, January 24, 2023
• Co-Author, “Top 5 IP Considerations for Medtech Companies Transitioning To Data-enabled Product Solutions,” MedCity News, January 20, 2023
• Co-Author, “Significant Regulatory, Compliance, and Enforcement Developments, 2021,” Food and Drug Law Institute’s Top Food and Drug Cases, 2021, & Cases to Watch, 2022
• Co-Author, "Emerging from the Laboratory: Regulatory Considerations," The Journal of Biolaw & Business, 2004
• Co-Author, "Part 11: The FDA’s New View," Bio-IT World, April 15, 2003
• Contributor, "Legal Responsibility for RA Professionals: Mistakes Can Be Costly," Regulatory Affairs Focus, April 1998