Linda D. Bentley: Lawyer with Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

Linda D. Bentley


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AV® Preeminent

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Practice Areas

  • Corporate & Securities
  • Securities & Capital Markets
  • Clinical Trials & Research
  • Medicare
  • Medicaid & Commercial Payor Coverage & Payment
  • Medical Technology
  • International
  • Product Risk Management & Response
  • Life Sciences
  • Insurance
  • Health Care
Contact InfoTelephone: 617.348.1784
Fax: 617-542-2241
Internet: Each Attorney's Internet Address takes the following form: first initial, last name (e.g.,
University Simmons College, B.S.
Law SchoolBoston College, J.D.
Admitted1983, Massachusetts

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

LanguagesFrench; 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.

•Quoted in Delays by DEA Regulators Imperil Access to Test for Parkinson's, BNA Health Law Resource Center (12.26.2014)
•Quoted in Attorneys: 'Proper Rulemaking' Better Than Guidance for LDTs, The Gray Sheet (12.15.2014)
•Quoted in Biosimilars Policy, Patents, Antitrust, Drug Compounding among Year's Key Topics, BNA's Pharmaceutical Law & Industry Report (01.08.2014)
•Quoted in China Drugmakers Face U.S. Scrutiny on Investigator Bump, Bloomberg (12.10.2013)
•Quoted in FDA Scrutiny Looms for Unapproved Research Tests, Law360 (11.25.2013)
•Quoted in User Fees Won't Save the FDA Approvals From Shutdown's Snare, Law360 (10.01.2013)
•Quoted in Mobile Health IT Firms Face Greater FDA Scrutiny, Boston Business Journal (06.14.2013)
•Quoted in Lawyers Weigh in on FDA App Guidance, Government Health IT (06.11.2013)
•Quoted in Experts See Biosimilars, Marketing, Patent Settlements among Year's Key Topics, BNA's Pharmaceutical Law & Industry Report (01.18.2013)
•Quoted in Tightening Oversight, Modern Healthcare (12.17.2012)
•Quoted in Critics Charge That Drug-Compounding Pharmacies Require Government Oversight, The Washington Post (10.18.2012)
•Quoted in Compounding Pharmacies: Where's the Oversight?, MedPage Today (10.12.2012)
•Quoted in Disease Outbreak All Too Common, USA Today (10.12.2012)
•Quoted in Meningitis Outbreak Puts Attention on Pharmacy Rules, The Tennessean (10.10.2012)
•Quoted in What Are Compounding Pharmacies?, Web MD (10.10.2012)
•Quoted in Md. Specialty Pharmacies Seek Distance from Meningitis Outbreak, The Baltimore Sun (10.09.2012)
•Quoted in User Fees, Drug Shortages, Off-Label Issues Among PLIR Board's Top Concerns for 201, BNA Pharmaceutical Law & Industry Report (01.13.2012)
•Quoted in Relocating Abroad, Modern Healthcare (10.24.2011)
•Quoted in FDA Releases Strategic Priorities That Will Guide Agency Through 2015, BNA's Pharmaceutical Law & Industry (04.29.2011)
•Quoted in PLIR Advisory Board Sees Biosimilars, Enforcement Among Top Concerns for 2011, BNA's Pharmaceutical Law & Industry (01.21.2011)
•Mintz Levin Represents Alphatec Holdings, Inc. in $92 Million Public Offering, (04.22.2010)
•Mintz Levin Represents Oppenheimer & Co., Inc. in Back-to-Back Closings of Two Offerings, (11.30.2009)
•Forty-Eight Mintz Levin Attorneys Recognized as Massachusetts Super Lawyers, (10.27.2009)
•Mintz Levin Represents Targacept Inc. in Public Offering, (10.20.2009)
•Forty-Five Mintz Levin Attorneys Recognized as Massachusetts Super Lawyers, (10.25.2007)

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

•Author, FDA Notifies Congress of Framework for Long-Awaited Guidance on Laboratory Developed Tests and Issues Final Guidance on Companion Diagnostics, Life Sciences/FDA Alert (08.25.2014)
•Author, FDA Issues Draft Guidance Easing Compliance for Medical Device Data and Image Systems, Medical Technology Alert (06.20.2014)
•Author, FDA Draft Guidance on In Vitro Companion Diagnostic Devices Provides an Outline but Few Specifics to Advance the Growth of Personalized Medicine, Life Sciences FDA Alert (07.22.2011)
•Author, New Guidance on RUOs and IUOs May Affect LDTs, Life Sciences FDA Alert (06.13.2011)
•Author, FDA Releases Criteria for Responsible Officer Prosecutions, Life Sciences Alert (02.14.2011)
•Co-author, New Proposed HIPAA Rules May Benefit Researchers, Health Law Advisory (08.09.2010)
•Co-author, New Proposed HIPAA Rules May Benefit Researchers, Life Sciences Advisory (08.09.2010)
•Co-author, Communications and Health Care Article: Radio Frequency Medical Devices at the Intersection of FCC, FDA and Privacy Concerns, Update Magazine (04.03.2007)

Speaking Engagements
•Panelist, Medical Devices: Health Information Technology and Laboratory Developed Tests, Food and Drug Law Institute's Annual Enforcement, Compliance and Litigation Conference, Washington, DC (12.08.2014)
•Speaker, Mobile Medical Apps, FierceMedicalDevices (03.27.2014)
•Speaker, Mobile Medical App Regulation, FierceMedicalDevices, Webinar (12.18.2013)
•Chair, Accelerating the Clinical Route to NDA/BLA Submission, The Massachusetts CRO/CMO Symposium: Accelerating Drug Development, Massachusetts Biotechnology Council, Newton, MA (02.25.2013)
•Panelist, Biosimilar Regulations and CMOs, FierceBiotech, Webinar (06.26.2012)
•Speaker, The Health Care Reform Law: Implications for the Medical Device Industry, Massachusetts Medical Device Industry Council, Webinar (05.25.2010)

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


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FDA Notifies Congress of Framework for Long-Awaited Guidance on Laboratory Developed Tests and Issues Final Guidance on Companion Diagnostics
Linda D. Bentley, September 1, 2014
After many years of promising that it would be providing guidance on the regulation of laboratory developed tests (LDTs), the Food and Drug Administration (FDA) provided notice to Congress on July 31, 2014 that it intends to issue a draft guidance document entitled, “Framework for Regulatory...

FDA Issues Draft Guidance Easing Compliance for Medical Device Data and Image Systems
Linda D. Bentley, June 27, 2014
In what has been an active couple of months of released guidance documents, the FDA issued another draft guidance on June 20, 2014 entitled, “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices.” The primary purpose of this draft guidance...

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Linda D. Bentley

BostonMA 02111


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