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Medical Devices Law and Regulation Answer Book (2014 Edition)

Author(s): Suzan Onel, Karen M. Becker, Ph.D.
Practice Area: Health Care, Intellectual Property
Date: Aug 2013 i Other versions can be found in the Related Items tab.
ISBN: 9781402420498
PLI Item #: 47819
The regulation of medical devices has grown increasingly complex since the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act (FDCA) were introduced in 1976.  Medical Devices Law and Regulation Answer Book 2014 walks you through the current regulatory requirements and describes every aspect from pre-market requirements for specific types of devices to post-market regulation and ongoing government enforcement and investigation.

With over 30 contributors from a variety of major law firms and consulting firms specializing in medical device work, Medical Devices Law and Regulation Answer Book 2014 provides practical guidance on how to handle every day questions on a wide variety of topics as well as what issues are likely to arise and how to avoid them.  The breadth of coverage of this new publication is illustrated by the chapter titles provided below:

  • Overview of Medical Device Regulation in the U.S.
  • Clinical Studies of Investigational Devices
  • Device Premarket Submissions
  • Devices with Unique Issues – Combination Devices, Radiological Devices, Restricted Devices, Customer Devices, Device Software
  • In Vitro Diagnostic (IVD) Devices
  • The Quality System Regulation
  • Device Facility Inspections
  • Post Market Considerations
  • International Considerations
  • Enforcement and Government Investigations Regarding Medical Devices
  • Interacting with FDA
  • Intellectual Property Considerations for Medical Device Companies
  • Fraudulent and Abusive Practices in the Reimbursement for Medical Devices
  • HIPAA’s Impact on the Medical Device Manufacturing Community
  • Continuing Medical Education (CME) and Industry-Supported Scientific Activities
  • Litigation, Product Liability, and Preemption
  • Licensing, Product Development and Commercialization
  • FDA Criminal Enforcement
  • Overlapping Jurisdiction with other Agencies and Law Enforcement Entities
  • Commonly Used Acronyms

With almost 30 years of experience, Suzan Onel advises FDA-regulated companies on regulatory, compliance, and enforcement issues involving medical devices, foods, dietary supplements, over-the-counter drugs, cosmetics and consumer products. She regularly advises international and domestic manufacturers, distributors, and researchers on market entry strategies, labeling and promotional activities, regulatory compliance, recalls and field corrections, and enforcement defense. Ms. Onel assists clients with the preparation of FDA submissions, including 510(k) premarket notifications, premarket approval applications (PMAs), food additive petitions, GRAS self-affirmations and notifications, food contact notifications, new dietary ingredient notifications, and adverse event reports. Ms. Onel’s experience includes representing clients before the U.S. Food and Drug Administration, the Federal Trade Commission, the U.S. Department of Agriculture, the Bureau of Alcohol, Tobacco, and Firearms, the National Advertising Division of the Better Business Bureaus, and similar international and state bodies.

Ms. Onel’s practice also includes FDA due diligence investigations and advising companies and private equity/venture capital investors on transactional matters involving life science company acquisition, divestment and capital growth as well as supplier contracts and clinical research agreements.


Karen M. Becker, Ph.D. joined Precision for Medicine in December 2012 as Managing Director of Translational and Regulatory Sciences, a Center of Excellence established to support research and development, commercialization programs, and regulatory approvals and com pliance for new health care products. Dr. Becker is an industry leader with over twenty­five years of experience serving hundreds of clients in a broad range of therapeutic areas, with a focus on scientific and regulatory services to companies operating at the intersection of science and public policy. Successful resolution of client matters is achieved through application of sound science, reliance on leading clinical and scientific expertise, and a commitment to outstanding quality and service. Prior to Precision, Dr. Becker was the Founder and Chief Executive Officer of Becker & Associates Consulting, Inc., a leading full­service scientific and regulatory affairs consulting firm, until its acquisition. She has published original research in pharmacology and drug development, numerous publications on FDA regulation, and a textbook on 
 the design of clinical trials for medical devices. Dr. Becker is an Adjunct Associate Professor at Georgetown University, where she teaches public health policy and biotechnology management. She received a Bachelor of Science in Biological Chemistry from the University of Maryland at College Park, and a Ph.D. in Pharmacology from the University of North Carolina School of Medicine.