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Linda D. Bentley

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Education

  • Boston College (JD)
  • Simmons College (BS)

Bar Admissions

  • Massachusetts

Languages

  • French
  • German
  • Hebrew

Linda chairs the firm’s FDA Practice Group. She has extensive experience representing pharmaceutical, biotechnology, medical device manufacturers, and insurers on corporate and regulatory matters.

Linda advises health products manufacturers on the regulatory and reimbursement status of products and procedures and on strategic pathways for bringing new products to market. She counsels clients on compliance with the Federal Food, Drug, and Cosmetic Act and related requirements, including arrangements for outsourced services, advertising and other promotional issues, and responses to 483s and Warning letters. She also provides advice on the regulatory issues relating to in vitro diagnostic products, including laboratory developed tests (LDTs) and companion diagnostics and on the regulation of mobile medical apps. She performs regulatory due diligence for financings and other corporate transactions and counsels clients on disclosure of clinical and other product information. In addition, she has worked with companies to obtain reimbursement from insurance companies, managed care organizations, and Medicare.

She serves as general counsel to a large municipal self-insurance pool. She has also assisted insurance companies in obtaining initial state licensure, amendments to existing licenses, insurance department approval of mergers and acquisitions, and responding to enforcements actions.

After graduating from law school, Linda served as senior counsel for the Massachusetts Division of Insurance, where she focused on the regulation of health insurance products and managed care organizations. She also advised the Commissioner of Insurance on insurance transactions, such as mergers and acquisitions, holding company transactions, and agent, broker, and company licensing.

Before attending law school, Linda worked for eight years at New England Nuclear/DuPont Medical Products, where she served as Director of Regulatory Affairs from 1976 to 1980. In that capacity, she established and implemented the company’s FDA policy and was responsible for obtaining marketing approval for new products in the United States, Canada, and other countries. She continued to provide FDA consulting services to pharmaceutical and medical device companies while she was in law school.

Recognitions & Awards

  • Martindale-Hubbell AV Preeminent
  • Massachusetts Super Lawyers: FDA (multiple years)

Professional & Community Involvement

  • Food and Drug Law Institute (FDLI): Medical Devices Committee
  • Massachusetts Medical Device Industries Council (MassMEDIC): Advisory Committee on In Vitro Diagnostics; Former Director
  • Director, MedTech IGNITE, a MassMEDIC program for medical device entrepreneurs
  • Advisory Board, Bloomberg BNA’s Pharmaceutical Law & Industry Report
  • Advisory Board, Bloomberg BNA’s Medical Devices Law & Industry Report
  • Member, American Health Lawyers Association
  • Member, Massachusetts Bar Association
  • Member, Boston Bar Association