Pamela Furman Forrest (Pam)

Pamela Furman Forrest is a partner in King & Spalding’s FDA & Life Sciences Practice Group.  Ms. Forrest joined the firm in 2007, bringing with her more than 12 years of experience in advising clients on a broad range of FDA regulatory issues.  Her practice focuses on FDA medical device matters, including premarket notification, premarket approval, product recalls, Medical Device Reporting (MDR), Quality System Regulation (QSR) compliance, establishment registration and device listing, labeling and promotion, reclassification, import/export issues and Investigational Device Exemption (IDE) requirements.  In addition, Ms. Forrest frequently assists medical device manufacturers, investment banks, and private equity funds with due diligence evaluations of FDA-regulated companies.

Ms. Forrest has written and spoken extensively on various aspects of FDA regulation of medical devices, and has testified before several State legislative committees regarding medical device legal and regulatory issues.

Ms. Forrest graduated summa cum laude, Phi Beta Kappa, from Yale University in 1988, with a Bachelor of Arts in political science.  She received her law degree from Stanford University in 1994.  Ms. Forrest currently serves on the Advisory Board of BNA’s Medical Devices Law & Industry Report.

Recent Publications

Published Works

• “Ensuring Effectiveness of Voluntary Medical Device Recalls,” Medical Device and Diagnostic Industry, March, 2011
  
  
• “Introduction to the Regulation of Medical Devices,” The Fundamentals of Life Sciences Law: Drugs, Devices, and Biotech, April, 2007
  
  
• “How FDA Hopes to Decrease Medical Errors with the Help of Bar Code Technology,” Health Lawyers News, December, 2005
  
  
• “How to Avoid an MDR Disaster: Set Up an Effective Reporting System,” Medical Device and Diagnostic Industry, June, 2005
  
  
• “FDA Considerations Related to Maintaining Clinical Trial Records in Electronic Form,” Health Lawyers News, December, 2004
  
  
• “The Increasing Impact of FDA Regulation on Hospitals and Related Institutions,” Health Lawyers News, December, 2003
  
  
• “The Impact of FDA Medical Device Regulation on Hospitals,” Health Law Digest, Volume 29, Number 1: 3-13, January, 2001

Presentations

• “Post-Market Information: New Uses and Challenges,” King & Spalding Medical Device Summit, Boston, Massachusetts, October 2010
  
  
• “Medial Device Essentials: Premarket and Postmarket Requirements,” FDA Boot Camp, Boston, Massachusetts, September, 2010
  
  
• “Building Effective Systems for Medial Device Reporting and Corrections/Removals,” King & Spalding Medical Device Summit, Menlo Park, California, June, 2009 
  
  
• “How to Avoid an MDR Disaster: Setting Up an Effective Medical Device Reporting System,” FDAnews Audioconference, July, 2008
  
  
• “Building an Effective and Streamlined Medical Device Reporting System,” King & Spalding Medical Device Summit, Chicago, Illinois, April, 2008 and San Francisco, California, October, 2007
  
  
• “Perspectives on Using FDA Counsel,” Orthopedic Surgical Manufacturers Association, St. Petersburg, Florida, January, 2008
  
  
• “FDA’s Postmarket Regulation of Medical Devices: Requirements, Common Pitfalls, and Recent Developments,” FDA Boot Camp; Basic Training for Products Liability and Patent Lawyers, San Francisco, California, May, 2007 and New York, New York, March, 2007
  
  
• “Classification of Medical Devices and the Essentials of the Device Approval Process,” FDA Boot Camp; Basic Training for Products Liability and Patent Lawyers, Boston, Massachusetts, July, 2007; San Francisco, California, May, 2007; New York, New York, March, 2007; Chicago, Illinois, September, 2006; and New York, New York, March, 2006
  
  
• “Postmarket Issues,” The Food and Drug Law Institute’s (FDLI) Introduction to Medical Device Law and Regulation, Washington, D.C., January, 2007
  
  
• “Off-Label Promotion -- Current FDA Policies and How to Comply,” Regulatory Affairs Professionals Society’s Advertising, Promotion & Labeling Conference, Denver, Colorado, May, 2006
  
  
• “MDRs -- An Industry Perspective,” North Central Association of Food and Drug Officials’ Spring 2006 Drug-Device Education Conference, Chicago, Illinois, March, 2006
  
  
• “FDA Awareness for Hospitals,” American Health Lawyers Association Conference on Legal Issues Affecting Academic Medical Centers and Other Teaching Institutions, Washington, D.C., January, 2006
  
  
• “Off-Label Promotion - Current FDA Policies and How to Comply,” The Institute of Medical Technology’s Seminar on Disseminating Off-Label Information, Washington, D.C., December, 2005
  
  
• “Establishing an Effective MDR System,” Medical Design and Manufacturing (MD&M) Conference, Minneapolis, Minnesota, November, 2005
  
  
• “Avoiding Pitfalls in Your Complaint-Handling and MDR System,” Medical Design and Manufacturing (MD&M) Conference, New York, New York, June, 2005
  
  
• “International Issues,” The Food and Drug Law Institute’s (FDLI) Introduction to Medical Device Law and Regulation, Washington, D.C., May, 2005 and November, 2004
  
  
• “Research and FDA-Related Issues,” American Health Lawyers Association (AHLA) Fundamentals of Health Law Seminar, Chicago, Illinois, November, 2004
  
  
• “FDA Medical Device Regulatory Issues Affecting Hospitals,” American Health Lawyers Association (AHLA) Annual Meeting, Orlando, Florida, June, 2001