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.
- 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.
- Chambers Global (2012)
- Life Sciences, Global-wide
- Chambers USA (2012)
- Life Sciences, Nationwide
- Life Sciences, CA
- Chambers UK (2012)
- Life Sciences, UK-wide
- Life Sciences, Regulatory, UK-wide
- Chambers Asia (2012)
- 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: Regulatory (Medical Devices), USA
- Leading: Life Sciences, England, EU, and USA
- Leading; Government Enforcement and Investigations, USA
- Leading: Regulatory, Belgium, England, EU, and USA
- Highly Recommended: Life Sciences, Belgium
- LMG Life Sciences (2012)
- Lifecycle Firm
- Recommended: Regulatory, FDA (Medical Devices)