Covington is regulatory counsel to both start-up companies and large corporations, spanning a range of medical devices including implants, surgical instruments, diagnostic and therapeutic equipment, in vitro diagnostic products, combination drug/device products, and computerized health information systems. Our lawyers advise clients on the full range of regulatory requirements and strategies for medical device product development -- clinical trials, marketing authorizations and approvals, humanitarian device exemption, dispute resolution proceedings, quality system regulations (QSRs), postmarket reporting and compliance, product recalls, and advertising and promotion. We also have experience with the electronic product standards and requirements that are also applicable to non-medical products such as laser products and sunlamps. In conjunction with our London and Brussels offices, we can efficiently advise companies on device regulatory requirements on a global basis. Our practical experience allows us to provide strategic advice that is sensitive to the interplay between regulatory issues and other important legal areas such as patent, antitrust, reimbursement, fraud and abuse, and product liability.
Representative Matters
- We advise companies on regulatory strategies for obtaining premarket approval or clearance for new devices, including assisting in the development of strategic plans, representation in the de novo classification process, and preparation for FDA meetings and Advisory Panel proceedings.
- We advise companies on issues relating to investigational device exemptions (IDEs) and humanitarian device exemptions.
- We have represented several companies in connection with appeals under FDA’s medical devices dispute resolution procedures.
- We have advised large and small companies in handling FDA inspections and responding to notices of inspectional observations and warning letters.
- We participate on promotional review committees and conduct comprehensive review of internet and social media promotion.
- We conduct regulatory due diligence in connection with acquisitions and IPOs.
- We advise companies on licensing and joint ventures relating to devices.
Accolades
- 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 (2005-2009)
- The Practical Law Company (PLC) - Life Sciences, Which Law Firm? (2011)
- Leading: Regulatory firm, EU, USA, and England
- The Practical Law Company (PLC) - Life Sciences, Which Lawyer? (2011)
- Regulatory (Medical Devices): Ellen Flannery
- Regulatory: Peter Bogaert, Grant Castle, Peter Barton Hutt, Richard Kingham, Michael Labson, Eugene Lambert, Gerald Masoudi, and Peter Safir
- Chambers USA - America's Leading Business Lawyers (2010)
- Healthcare/Pharmaceutical/Medical Products Regulatory (DC): Ellen Flannery, Peter Barton Hutt, Richard Kingham, Michael Labson and Peter Safir
- Life Sciences/Regulatory/Compliance (National): Richard Kingham
- Chambers UK (2011)
- Life Sciences, Regulatory/Compliance: Richard Kingham and Grant Castle
- Chambers Asia (2011)
- Life Sciences, Regulatory: Jason Ma
- Legal 500 UK (2010)
- Pharmaceuticals and Biotechnology
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