Covington’s premier Food & Drug Practice includes longstanding representation of clients in the medical devices and diagnostics field. Covington lawyers act as regulatory counsel to medical device companies ranging from start-up ventures to large, multinational manufacturers. Our expertise spans a diverse range of device categories and classifications:
- Therapeutic devices, such as implants, surgical tools and instruments, kits, and accessories;
- Diagnostic devices, including in vitro diagnostics and imaging devices;
- Combination drug/device or biologic/device products;
- Medical software, mobile medical apps, and health information systems; and
- Cardiovascular, orthopedic, ophthalmic, neurological, gynecological, urological, dental, and other device classes.
Because of our long and deep work in the medical device industry, Covington lawyers not only are familiar with the governing laws and regulations, but also have broad-based practical experience with their application. This experience allows us to provide our clients with advice and representation that spans the lifecycle of their products:
- Preclinical and clinical trials, including pre-submissions and investigational device exemptions (IDEs);
- Premarket authorizations, such as premarket notifications (510(k)s), premarket approval applications (PMAs), de novo applications, and humanitarian device exemptions (HDEs);
- Dispute resolution, including informal pathways and formal proceedings;
- Quality system regulations (QSRs);
- Postmarket reporting and product recalls;
- Advertising and promotion;
- Compliance policies and systems; and
- Enforcement actions and litigation.
Our matters include advocacy before FDA and other federal agencies. We also have extensive experience conducting regulatory due diligence in connection with mergers, acquisitions, and IPOs. We are especially sensitive to the interplay between regulatory issues and other important legal areas such as patent, antitrust, FCPA, and product liability.
Covington lawyers advise on evolving FDA policies regarding diagnostics and radiological imaging, such as companion diagnostics, computer assisted detection (CAD), and innovative laboratory developed tests (LDTs). Our knowledge of the Federal Food, Drug, and Cosmetic Act (FDCA), the Clinical Laboratory Improvement Amendments (CLIA), state laws, and evolving FDA regulatory policy allow us to provide strategic insight to our clients in the pharmaceutical, device, diagnostics, and clinical laboratory industries.
Covington’s regulatory practice has global reach through our offices in Washington, London, Brussels, Beijing, and Seoul. Our European offices advise our clients on current and proposed device regulatory requirements in the European Union, as well as issues involving borderline products and combination products. Through strategic alliances, Covington can effectively advise companies about regulatory requirements on a global basis.
Representative Matters
- Strategic advice to and representation of numerous medical device companies seeking FDA clearance and approval of new products.
- Strategic advice to and representation of companies seeking EU marketing authorization for devices, diagnostics, and imaging products.
- Advising a large device company on regulatory requirements for clinical trials of medical devices in China.
- Strategic advice to and representation of companies in IDE and pre-submission matters.
- Representing medical device manufacturers and individuals in negotiating consent decrees with FDA, litigation involving seizures of product, and civil penalty proceedings.
- Drafting standard operating procedures (SOPs) and guidelines for the creation, review, and use of promotional materials for medical device manufacturer.
- Advising companies with respect to FDA and Congressional inquiries.
Accolades
- Law360, Life Sciences Group of the Year (2012)
- Chambers Global (2013)
- Life Sciences, Global-wide
- Life Sciences, Europe-wide
- Chambers USA (2013)
- Life Sciences, Nationwide
- Life Sciences, CA
- Chambers UK (2013)
- Life Sciences, UK-wide
- Life Sciences, Regulatory, UK-wide
- Chambers Asia (2013)
- Life Sciences (International Firms), China
- PLC Cross-border Super League
- Ranked 1st in the Life Sciences Regulatory Super League (2004-2011)
- Ranked 1st in the Life Sciences Industry Super League (2005-2010)
- PLC - Life Sciences, Which Law Firm? (2012)
- Leading: Life Sciences, England, EU, and USA
- Leading: Regulatory, Belgium, England, EU, and USA
- Leading: Government Enforcement and Investigations, USA
- Highly Recommended: Life Sciences, Belgium
- LMG Life Sciences (2012)
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