professionalIMG

Linda D. Bentley

Member vCard


Education

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

Bar Admissions

  • Massachusetts

Languages

  • French
  • German
  • Hebrew

Linda has extensive experience representing pharmaceutical, biotechnology, and medical device manufacturers on corporate and regulatory matters and on the business, strategic and legal considerations in bringing products to market.  She also performs regulatory and clinical diligence for underwriters, bankers and others investing in life science companies.

Linda advises health products manufacturers on compliance with the Federal Food, Drug, and Cosmetic Act, including the regulatory issues relating to in vitro diagnostic products such as laboratory developed tests (LDTs) and companion diagnostics, and on the regulation of combination products, mobile medical apps, and cell, tissue and gene therapies. She also provides advice on arrangements for outsourced services, advertising and other promotional issues, and responses to FDA Warning letters.  Because of her extensive knowledge of the requirements that apply to most types of FDA-regulated businesses, she is able to efficiently perform regulatory due diligence for financings and other corporate transactions and counsels clients on disclosure of clinical, regulatory and other product-related information. In addition, she has worked with companies to obtain reimbursement from insurance companies, managed care organizations and Medicare.

Before attending law school, Linda worked at New England Nuclear/DuPont Medical Products, where she served as Director of Regulatory Affairs. In that capacity, she established and implemented the company’s FDA policies and was responsible for administering clinical trials and instrumental in obtaining marketing approval for several 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
  • Former Director, Massachusetts Medical Device Industries Council (MassMEDIC) (2000-2006)
  • Member, MassMEDIC FDA Working Group
  • Former Director, MedTech IGNITE, a MassMEDIC program for medical device entrepreneur (2006-2015)
  • 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