Covington acts as regulatory counsel to device and diagnostics companies ranging from start-up ventures to multinational manufacturers, clinical laboratories, and industry trade associations. We advise on the full range of regulatory requirements and strategies for the entire product lifecycle. Through our offices in the US, Europe and Asia, and strategic alliances in other key jurisdictions, Covington effectively advises device and diagnostic clients on a global basis. Our team includes lawyers with experience at FDA.
Covington has extensive, global experience advising device and diagnostic clients with respect to the full range of regulatory matters—presubmission strategy, clinical trials, marketing authorizations, supervisory review and dispute resolution proceedings, manufacturing and quality systems compliance, postmarket reporting, and advertising and promotion. Our lawyers worldwide work seamlessly to deliver comprehensive and insightful advice and representation with national and regional expertise.
We have experience with a wide range of medical devices. We advise on evolving FDA policies regarding mobile apps, companion diagnostics, radiological imaging products, and laboratory developed tests (LDTs). Our knowledge of the Federal Food, Drug, and Cosmetic Act (FDCA), the Clinical Laboratory Improvement Amendments (CLIA), state laws, and FDA regulatory policy allows us to provide strategic insight to our clients.
We also handle issues involving combination products, and advise pharmaceutical and biotechnology companies regarding medical device requirements relevant to their pharmaceutical products and strategic partnerships.
We conduct regulatory due diligence in connection with mergers, acquisitions, and IPOs, including review of premarket notifications (510(k)s), premarket approval applications (PMAs), investigational device exemptions (IDEs), and other FDA regulatory files. Our due diligence frequently includes postmarket requirements, including adverse event reporting, sales and marketing compliance, compliance with FDA’s quality system regulation, and an array of other issues.
We also advise clients on many types of enforcement matters, including responding to notices of inspectional observations and warning letters, product seizures, recalls, injunctions, civil penalties, and criminal proceedings. We have negotiated consent decrees and voluntary agreements arising out of medical device quality systems, manufacturing practices, and promotion issues.
We have been involved with all of the major legislative initiatives that have affected medical device regulation since the Medical Device Amendments of 1976, including the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), the Food and Drug Administration Amendments Act of 2007, the Medical Device User Fee and Modernization Act, the Food and Drug Administration Modernization Act of 1997, and the Safe Medical Device Act of 1990.
Our European team advises clients on current and proposed device regulatory requirements in the European Union, including the proposed changes to the device regulatory framework. We review regulatory documents such as certifications or registrations, and the underlying technical documentation, facility permits, and inspection reports, both from self-audits or those by third parties, such as inspections by notified bodies and European health authorities. We also advise on safety notifications and compliance matters.
Our China team, including members in Beijing and Shanghai, advises companies on the regulatory requirements of the China FDA and provincial FDA authorities regarding clinical trials, premarket review and approval, manufacturing practices, import requirements, and postmarket compliance matters. The team is led by the managing director of our Asia food, drug and device practice, who has over 10 years of experience in this field.
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