Stephanie Philbin

Ms. Philbin frequently lectures on food and drug law. Most recently, in September 2019, she presented on ““Medical Devices, Combination Products, Companion Diagnostics, and Medical Apps: A Review of FDA Guidelines and Regulations” at the American Conference Institute’s 34^th FDA Boot Camp. Her other speaking engagements include:

• “Dealing with Adverse Events/Product Problems” for the Food and Drug Law Institute/Center for Devices and Radiological Health In-House Training Course: Introduction to Medical Device Law and Regulation (June 2019, October 2015, April 2015 and November 2014)
• “Post Marketing Issues” at the Food and Drug Law Institute’s Introduction to U.S. Medical Device Law and Regulation (April2019, July 2018 and May 2014)
• “Overview of Reportable Malfunctions” at Q1 Productions’ 5^th Annual Medical Device Postmarket Surveillance (January 2019)
• “The Regulation of Digital Health and Health IT” at the Canadian Consulate General’s Canadian Technology Accelerator (October 2018)
• “FDA Regulation of Digital Health and Health IT” in Wolters Kluwer’s Health Law Thought Leadership webinar (May 2018)
• “Premarket Notification 510(k)s and De Novo Applications” at the Food and Drug Law Institute’s Introduction to U.S. Medical Device Law and Regulation (April 2018)
• “Postmarket Surveillance and Remediation” at the MedTech Intelligence Medical Device Cybersecurity Workshop (October 2017)
• “Regulations and Definitions” at MedTech Intelligence’s Medical Device Recalls (November 2016)
• “Medical Device Reporting” at the American Conference Institute’s FDA Boot Camp: Devices Edition (July 2016)
• “Presenting Risk Information in Promotional Materials and Updated Good Reprint Practices” at AdvaMed’s Advertising and Promotion of Medical Devices Program (November 2014 and November 2013)
• “Fundamentals of FDA Regulatory Device Law” and “Comprehending the 510(k) Clearance Process” at the American Conference Institute’s FDA Boot Camp Devices Edition (October 2012)
• “The Food and Drug Administration Safety and Innovation Act: The 2012 Device Amendments and Their Potential Effect” in a Bloomberg BNA webinar (October 2012)
• “Off-Label Issues: Scientific Exchange and Unsolicited Requests” at the AdvaMed 2012 MedTech Conference (October 2012)
• “Medical Devices: Classification and the Essentials of the Device Premarket Review Process” at the American Conference Institute’s FDA Boot Camp (March 2012 and March 2010)
• “Enforcement and Compliance” for the Food and Drug Law Institute’s Introduction to Medical Device Law and Regulation (March 2012 and March 2010)
• “Premarket Approval Application” at the American Conference Institute's FDA Boot Camp Devices Edition (October 2011)
• “Changes to FDA’s 510(k) Program” in a BNA webinar (May 2011)
• “Legal Considerations: Industry Use of Social Media” at MassMEDIC's program on Use of Social Media During Regulatory Uncertainty (May 2011)
• “The FDA, the Internet & Social Media: Regulatory Issues and Evolving Policy” before the Medical Development Group (September 2010)
• “Post Marketing Issues" and "Quality System Regulation (QSR)” for the Food and Drug Law Institute’s Introduction to Medical Device Law and Regulation (January 2010)
• “Presenting Risk Information in Promotional Materials” at 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)
• “Post-Market Requirements and Concerns for Medical Devices” at the American Conference Institute’s FDA Boot Camp (July 2007)
• “Device Postmarket Reporting in the Drug Safety Age” for AdvaMed (November 2006)
• “Preparing for and Responding to an FDA Inspection” for AdvaMed (May 2005)
• “Medical Device Technologies and the FDA: GMPs for Combination Products” at the Virginia Biotechnology Summit (2004)

Ms. Philbin has co-authored numerous articles including “Emerging from the Laboratory: Regulatory Considerations” (The Journal of Biolaw & Business, 2004, co-authored with Mark A. Heller and Melisa Moonan), and “Part 11: The FDA’s New View” (Bio-IT World, April 15, 2003, co-authored with Mark A. Heller). She also contributed to “Legal Responsibility for RA Professionals: Mistakes Can Be Costly” by Mark A. Heller (Regulatory Affairs Focus, April 1998).