Within the Health Care and Life Sciences practice, we have a special focus on the medical device industry. We are thought leaders in medical device regulation, and our attorneys have been involved in most of the important regulatory and payment issues affecting the device industry.

We represent medical device companies of all sizes in health law matters, including Medicare and FDA-related issues. From a technology standpoint, our clients include many of the largest manufacturers of:

  • In vitro diagnostic products
  • Hospital beds
  • Durable medical equipment
  • Orthopedic implants
  • Cardiovascular products
  • Drug delivery products
  • Other combination products

Epstein Becker Green attorneys also have an in-depth focus on the regulation of mobile health, telemedicine, health information technology, and other software used in the health care context. In that regard, we represent a number of manufacturers of wireless health technologies as well as the Continua Health Alliance, the mHealth Regulatory Coalition, and the CDS Coalition. Through these representations, we have been integrally involved in the development of global regulatory policy for mHealth and clinical decision support software.

Our attorneys have written textbooks and numerous chapters explaining medical device law and regulation, testified before Congress on these issues, and taught at top U.S. law schools. Moreover, one of our attorneys, in the mid-1990s, spearheaded the effort to convince the FDA to adopt Good Guidance Practices. Another of our attorneys headed the effort at the turn of the 21st century to convince what was then the Health Care Financing Administration to make more public the Medicare coverage determination process and the proceedings of the agency's advisory committee.

Services/Scope of Practice

Epstein Becker Green provides complete legal support for medical device manufacturers on all regulatory and payment matters. Our services include:

  • Helping clients manage FDA inspections, improve quality systems, and design practical and effective compliance systems
  • Developing, drafting, and implementing market introduction strategies for complex technologies that don't fit neatly into existing pathways
  • Establishing strategic marketing claims for maximum reimbursement, with a special focus on the evidence requirements for FDA clearance, and helping clients navigate the coding, coverage, and payment system
  • Developing an appropriate set of Good Promotional Practices ("GPPs") that are specific to the manufacturer and guide its marketing campaigns in effective directions
  • Providing counsel on privacy and security matters to manufacturers not covered by HIPAA that may contract with, or provide equipment and services to, covered entities and business associates, and devising strategies for anticipating customer demands and for common law and consumer privacy compliance
  • Providing counsel regarding risk management during clinical trials, and drafting policies, GPPs, appropriate contractual agreements, and informed consent forms that align with company policies and procedures
  • Representing clients during noncompliance matters
  • Analyzing the impact on current and pending legislation and regulations that address FDA issues
  • Defending medical device manufacturers in litigation involving federal and state agencies, as well as qui tam or "whistleblower" actions started by individuals acting in the name of the government and seeking a share of any recoveries, and helping clients with investigations
  • Structuring, negotiating, documenting, and implementing complex health care transactions (such as mergers and acquisitions), for medical device manufacturers, including conducting health regulatory due diligence, addressing potential health regulatory exposures, and overseeing compliance audits
  • Guiding companies in the drug, device, and biologics industries, including members of the Combination Product Coalition, on actively communicating the industries' concerns and desires with respect to new combination product policies at FDA

Epstein Becker Green also assists medical device manufacturers with a wide range of services related to federal and state transparency reporting, including:

  • Counseling on legal requirements and the interpretation of relevant laws and regulations
  • Conducting assessments designed to identify gaps in federal and state transparency reporting compliance
  • Implementing action plans to correct deficiencies in the implementation of federal and state transparency reporting compliance
  • Devising strategy for addressing infrastructure and resource matters
  • Advising on the implementation of aggregate spend reporting systems and coordination with third-party vendors
  • Drafting policies, procedures, and working instructions to capture the implementation of state and federal law requirements
  • Training sales forces, home office personnel, and other relevant employees and vendors regarding federal and state transparency reporting requirements
  • Training health care professionals regarding federal and/or state transparency reporting requirements
  • Preparing transmittal letters and other communications with relevant government agencies
  • Drafting comments to proposed regulations
  • Responding to inquiries from government authorities and other third-party inquiries
  • Analyzing preemption matters
  • Informing clients of federal and state law developments

Client Successes

  • Leading the effort, due to our long involvement with in vitro diagnostic clients, to move the administration of CLIA from the Centers for Disease Control and Prevention to the FDA and to improve the operation of the waiver petition process
  • Reviewing the promotional practices of one of the world's largest medical device manufacturers, then working with executive management to create a set of GPPs to ensure compliance with FDA and fraud and abuse requirements
  • Helping a client respond to multisite FDA inspections that resulted in multiple Form FDA-483s, Untitled Letters, and Warning Letters; then assisting the same client with structuring and executing a company-wide remediation to improve compliance with FDA requirements
  • Conducting a due diligence review of a medical device manufacturer that uncovered significant FDA compliance issues previously unknown to the potential investors
  • Drafting and negotiating clinical trial agreements for a pivotal Phase III study, then transitioning the company to a treatment protocol and cost recovery program while FDA marketing applications were being compiled, submitted, and reviewed by the FDA
  • Helping a tissue product manufacturer interpret the nuances of marketing and promotional issues for tissue products and medical devices, and applying those nuanced requirements to their website and other marketing practices
  • Training a major medical device manufacturer on Good Clinical Practices and other clinical trial issues, then assisting the manufacturing in enhancing its clinical research SOPs to reflect current requirements and best practices
  • Creating for a major electronics manufacturer an extensive regulatory and reimbursement strategy for telehealth products, and advising management on the potential risks and benefits to various pathways
  • Helping a multibillion-dollar drug and combination product manufacturer execute a recall on a major product line