Overview
Medical device companies of all sizes turn to Epstein Becker Green to represent them in a wide variety of health law matters, including Medicare and FDA-related issues.
Within our 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.
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 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.
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
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Focus Areas
Experience
Contacts
- Member of the Firm
- Board of Directors / Member of the Firm
- Member of the Firm
Media
Events
Past Events
- October 12, 2022
- September 15-16, 2022
- September 9, 2022
- August 25, 2022
- July 28, 2022
Insights
Insights
- BlogsUnpacking Averages: Analyzing FDA Device-Related Citizens Petitions by Topic10 minute read
- BlogsSharing Scientific Information with HCPs on Unapproved Uses of Medical Products: Dos and Don’ts Under FDA’s New Draft ...14 minute read
- Media CoverageBradley Merrill Thompson Quoted in “The Problem with FDA's Warning to Abiomed”5 minute read
- PublicationsNavigating the Medtech GenAI Journey: A Policy Primer2 minute read
- PublicationsORI Releases Notice of Proposed Rulemaking to Update 2005 Public Health Service Policies on Research Misconduct ...7 minute read
- BlogsUnpacking Averages: FDA’s Extraordinary Delay in Resolving Citizen Petitions17 minute read
- Media CoverageJames Boiani Quoted in “Proposed FDA Rule Sets Stage for New Round of Battle Over LDT Regulation”5 minute read
- BlogsFull Steam Ahead: FDA Releases Proposed LDT Rule in Advance of Looming Government Shutdown4 minute read
- Media CoverageJames Boiani Quoted in “FDA Wants Oversight of Lab-Developed Tests”2 minute read
- PublicationsA Topic-Based Analysis of FDA Responses to FOIA Requests1 minute read
- Media CoverageJames Boiani Quoted in “NY State Database Offers Glimpse into Laboratory-Developed Testing Landscape”3 minute read
- Media CoverageJames Boiani Quoted in “FDA Moves to Modernize Medical Devices Premarket Program”3 minute read
- PublicationsState Regulation of Pharmacy Benefit Managers: Tenth Circuit Holds That ERISA and Medicare Part D Preempt Key Parts of ...25 minute read
- Media CoverageEpstein Becker Green Update Cited in “Physicians Could Be in Financial Danger with This Stark Law Change”2 minute read
- Media CoverageBonnie Odom Quoted in “Health Care’s AI Embrace Boosts Workforce Despite Privacy Risks”2 minute read
- BlogsUnpacking Averages: Analyzing the Relationship Between MDRs and Recalls21 minute read
- BlogsTAKE TWO: CMS’s Second Attempt to Streamline Breakthrough Device Coverage Limited to 5 Devices Per Year26 minute read
- PublicationsEuropean Commission Adopts an Adequacy Decision for a New EU-U.S. Data Privacy Framework6 minute read
- Media CoverageRachel Snyder Good Featured in “The Top Mid-Law People Moves of 2023 So Far”2 minute read
- PublicationsWhat’s on the Agenda? Laboratory Developed Tests Added to the Unified Regulatory Agenda Signals FDA Movement Toward New ...26 minute read
- Firm Announcements
Elizabeth Scarola Named to the 2023 Florida Rising Stars List
6 minute read - Media CoverageHemant Gupta, Jeff McGoff, and Adelee Traylor Featured in “Epstein Becker Grows Health Care Practice in Dallas ...3 minute read
- Media CoverageHemant Gupta, W. Jeff McGoff, and Adelee Traylor Featured in “Wake Up Call: Laterals, Moves, In-House”1 minute read
- Firm AnnouncementsEpstein Becker Green Adds Health Care Transactional, Technology & IP Attorneys in Memphis and Dallas Amid Ongoing Expansion ...4 minute read
- Media CoverageAlaap Shah Quoted in "New Health App Rule Would Better Protect Users – and So Can You"2 minute read
- Firm Announcements
Jessika Tuazon Named to the 2023 Southern California Rising Stars List
6 minute read - PublicationsFDA Issues Draft Recommendations for Implementing Decentralized Clinical Trials20 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Draft Guidance Allows AI/ML Devices to Evolve Without Requiring New ...5 minute read
- PublicationsBradley Merrill Thompson Quoted in “FDA’s Human Factors Draft Draws Fire for Introduction of ‘Critical Task’ ...2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Outlines Plan for Digital Health Technologies for Clinical Trials”4 minute read
- Firm Announcements
Epstein Becker Green Recognized Among Top 10 Largest Health Care Law Firms by Modern Healthcare
2 minute read - PublicationsDOJ’s Antitrust Division Continues Its Pursuit of Overlapping Directorates2 minute read
- Firm AnnouncementsRachel Snyder Good, Health Care Attorney, Former Advisor to U.S. House of Representatives Majority Leader Steny H. Hoyer ...3 minute read
- Media Coverage
Rachel Snyder Good Featured in Law360 Pulse
2 minute read - Media CoverageJames Boiani Quoted in “FDA Resumes Move to Regulate LDTs, Likely Setting Up Legal Battle with Lab Industry” ...3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Growth of AI in Mental Health Raises Fears of Its Ability to Run Wild”4 minute read
- Media CoverageBradley Merrill Thompson Quoted in “The FDA Plans to Regulate Far More AI Tools as Devices. The Industry Won’t Go Down ...2 minute read
- Media CoverageBradley Merrill Thompson Discusses FDA Regulatory Hurdles for Breakthrough Devices2 minute read
- Media CoverageBradley Merrill Thompson and the CDS Coalition Request FDA Rescind Final Decision Support Guidance2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Why Congress Quietly Just Gave the FDA More Power”3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Industry Group Petitions FDA to Withdraw CDS Guidance”5 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Trade Group Pushes Back on FDA’s Clinical Decision Support Guidance”3 minute read
- PublicationsCongress Clarifies the Regulatory Classification of Contrast Agents, Radioactive Drugs, and OTC Monograph Drugs ...14 minute read
- PublicationsRecap: Top 10 Antitrust Issues in 20222 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Outlook 2023: The Regulatory Path Ahead”2 minute read
- Media CoverageElizabeth Scarola Featured in “People on the Move”1 minute read
- Firm AnnouncementsEpstein Becker Green Announces 2023 PromotionsOctober 28, 20225 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Torres Says Regulatory Alignment a Pressing Consideration for AI Change Control ...2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA’s Tweak of Mobile Medical Apps Guidance Introduces Transparency ...2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Acknowledges Shortcomings of Pre-Cert Pilot in Report”6 minute read