Medical Devices

Holland & Knight's Medical Devices Team takes a comprehensive, multidisciplinary approach to serving the needs of medical device clients. Our attorneys have the range of legal experience essential for dealing effectively with increasingly complex regulatory and policy challenges throughout a product's life cycle.

We have broad experience counseling clients on all aspects of a complex regulatory landscape, including review and approval by the FDA Center for Devices and Radiological Health (CDRH), navigating issues such as product classification, clinical trial design, selection of the best pathway to market, Institutional Review Board (IRB) approvals and investigational device exemptions (IDEs), 510(k) and Premarket Approval applications, labeling, relabeling and repackaging requirements, and quality management systems.

In addition, our lawyers advise on important Medicare compliance issues, including pricing, contracting, rebates and patient assistance programs. We also negotiate with payers to cover and approve new products, as well as help structure and implement marketing and sales practices to comply with the federal Anti-Kickback Statute (AKS) and related laws and regulations.

Representative Matters

Our Medical Devices Team has extensive experience helping clients resolve regulatory, transactional and IP challenges, including the following:

FDA, CDRH and Related Issues

• Developing clearance and approval strategies for medical devices and combination products
• Guiding clients through clinical trial design, IRB approvals and investigational device exemptions
• Counseling on labeling, relabeling and repackaging requirements
• Defending clients in FDA-initiated enforcement actions and inspections
• Advising on supply chain issues such as importation, e-commerce, counterfeiting, wholesalers and pedigree requirements, and radio frequency identification (RFID) policy and technology
• Advising on marketing and labeling issues, including advertising, protected speech and on/off label marketing
• Providing guidance on voluntary codes regarding marketing practices and interaction with healthcare professionals, as well as continuing medical education
• Advising on prescription-to-nonprescription (Rx-OTC) switch issues
• Applying for Emergency Use Authorization (EUA) for a device, including responding to the FDA's follow-up questions and separate scrutiny of the company's claims about its product
• Lobbying on major FDA, Medicare and device importation legislation
• Creating a coalition of interested organizations to advocate before the FDA

Regulatory Compliance

• Providing regulatory guidance and advice on matters concerning compliance with the federal AKS, Stark law, Medicare, Medicaid, Physician Payments Sunshine Act, corporate practice of medicine, and other federal and state healthcare laws and regulations
• Drafting policies and procedures and implementing compliance programs
• Conducting in-depth compliance training for sales and marketing personnel, providing day-to-day advice on marketing regulations and reviewing marketing or promotional materials
• Appealing Medicare and state Medicaid payment audits
• Advising device manufacturers on how items and services are covered, paid for and reimbursed within various payment programs, including Medicare, Medicaid, Children's Health Insurance Program (CHIP), Affordable Care Act exchanges and nontraditional value-based care payment methods
• Negotiating with different programs and payers for coverage and approval of clients' products
• Reviewing and structuring rebate arrangements, discount arrangements, reimbursement strategies and other patient assistance programs, including the 340B program, copay assistance programs and other mechanisms to reduce the cost of devices

Transactional Advice

• Counseling clients, including private equity firms, in a variety of corporate and contractual transactions, including mergers and acquisitions, joint ventures, licensing, financing and services-related transactions
• Reviewing service agreements, licensing and other healthcare regulatory aspects of transactions
• Assessing risks, compliance programs, market strategies, payer agreements and contracted service providers
• Onboarding new personnel, conducting training and implementing compliance programs and strategies after transactions are complete
• Drafting agreements related to distribution, compliance, compliance functions, service providers, sales, organization, analytics and ancillary services after deals are complete
• Providing counsel through extended and complex auction processes, including amending critical license agreements with third parties

IP and Related Matters

• Assessing IP asset value of medical device companies being bought or sold, including strength of patents against potential competitors
• Advising major cancer and other academic medical centers on complicated, multilayered license agreements for products in various stages of scientific development and patent prosecution
• Providing guidance on FDA-related IP matters with an experienced team of IP litigators and prosecutors, including patent attorneys and agents with advanced degrees in science and engineering
• Advising on scrutiny of antitrust issues by the Federal Trade Commission and U.S. Department of Justice (DOJ)

Litigation

• Serving as national counsel in ongoing medical device litigation that now has more than 45,000 pending cases
• Counseling on scientific, medical and regulatory issues in product liability cases, expert discovery and motions, preemption and novel theories of liability
• Representing companies in commercial disputes, False Claim Act cases and other cases pending in courts in the U.S. and around the world
• Advising clients in responding to government investigations and CIDs
• Analyzing the merits of the government's cases and assisting with response drafting and document production
• Addressing compliance concerns that occur as a result of litigation
• Representing clients in state and federal courts and before state and federal regulatory and law enforcement authorities, including the DOJ, U.S. Attorneys' offices, state attorneys general offices, U.S. Drug Enforcement Administration (DEA) and the Office of Inspector General for the U.S. Department of Health and Human Services (HHS)