Medical Devices

Arnold & Porter represents 80% of the top 10 medical device companies, with cross-border capabilities spanning our regulatory, litigation, intellectual property, and transactional offerings. We support clients – from physician/founders to multinational medical device and medical technology companies – to successfully engage with global health authorities and other entities that oversee the development, manufacturing, conformity assessment, and marketing of products regulated as medical devices. 

Our U.S. FDA practice is mirrored by our European life sciences regulatory practice, and we are one of the few U.S.-headquartered firms with dedicated medical products regulatory professionals in China. We also counsel companies in times of crisis, be they difficult regulatory inspections, recalls, internal compliance audits, state and federal government investigations, litigation, or Congressional inquiries. We partner with colleagues across the firm to offer an interdisciplinary team that is positioned to support medical device and medical technology manufacturers across the full spectrum of their global needs.

Our preeminent coverage and reimbursement team tackles some of the most difficult pricing, reimbursement, and procurement challenges. Our capabilities include advice on coverage, coding, and payment rules for all sites of care and types of products; strategies to obtain new technology and pass-through status; benefit category determinations; CPT and HCPCS coding; national and local coverage issues including coverage with evidence development; parallel review of new products by the FDA and Centers for Medicare and Medicaid Services (CMS); and interacting with CMS on problematic reimbursement issues. We also work with the Agency for Healthcare Research and Quality, the National Institutes of Health, and FDA. Our Intellectual Property team has a strong track record of enforcing and defending patent rights for medical device companies. With a primary focus on litigation and trial excellence, much of our medical device IP work involves our clients’ most important products. Other areas of focus include: International Trade Commission Investigations; post-grant proceedings (IPRs and PGRs); ex parte reexamination; integrated patent/regulatory exclusivity advice; coordinated patent/antitrust counseling; patent procurement and prosecution; trademark prosecution, counseling and enforcement matters; and domain name disputes.