, Washington, D.C.
To commercialize innovative products, medical device developers must address issues such as regulatory clearance or approval, patents, financing, manufacturing, and distribution in an increasingly complex global market. We help clients mitigate risks and pursue opportunities through timely, effective counsel on matters relating to the entire medical-device life cycle. From inception and approval to debut and product maturity, you will benefit from guidance that reflects your business strategies and legal needs.
Our clients include local, regional, and global developers; manufacturers; researchers; investors; and trade associations. Many of our lawyers and regulatory science professionals have worked for regulatory agencies and in private industry, and have advanced degrees in relevant scientific or technological areas. We advise clients on all aspects of regulation involving the U.S. Food and Drug Administration (FDA), the European Union, and other local, national, and international regulatory entities. We also work with colleagues in our Life Sciences practice, ranked as a global leader by Chambers
, along with dedicated teams in the areas of regulatory compliance; health coverage, reimbursement, and pricing; fraud and abuse prevention; legislation and policy; intellectual property; financing; product liability; litigation and investigations; licensing and technology transfer; international trade; and pharmaceuticals and biotechnology.
Awards and Rankings
- Ranked as a leading firm for life sciences: regulatory and regulatory (medical devices) in the US, PLC Which Lawyer, 2012
- Ranked number one in PLC's Life Sciences Regulatory and Industry Super Leagues, 2012
- Ranked in the first tier for pharmaceutical/medical products regulatory practice, Chambers USA,2012
- Ranked in the first tier for EU Regulatory and Pharmaceutical, Legal 500: Europe, Middle East & Africa, 2010
Former Leadership Positions
- Steve Datlof, member of the clinical faculty at Temple University School of Medicine
- Howard Holstein, Associate Chief Counsel at the FDA and Vice President and General Counsel of the Health Industry Manufacturers Association (now called AdvaMed)
- Joe Levitt, Director, Center for Food Safety and Applied Nutrition, FDA; Deputy Director for Regulations and Policy, the FDA's Center for Devices and Radiological Health; Executive Assistant to the FDA Commissioner and other senior positions in the Commissioner's office
- Gerry Prud'homme, member of the research faculty at the University of Maryland School of Medicine; biostatistician
- John Smith, associate professor, Massachusetts General Hospital/Harvard Medical School; Director of Regulatory Affairs at the Center for Integration of Medicine and Innovative Technology (CIMIT); Co-Director, Massachusetts General Hospital Center for Biomarkers in Imaging; consultant, Radiological Devices Panel, the Medical Devices Advisory Committee, the FDA's Center for Devices and Radiological Health