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Medical Devices

Steptoe’s Environment & Life Science Group advises medical device manufacturers with regard to US Food and Drug Administration and international laws and regulations pertaining to medical devices.  Our lawyers regularly assist clients on regulatory strategies for placing new and/or modified medical devices on the market, including demonstrating in coordination with our scientific staff that the required safety requirements have been met.  Our integrated team of lawyers, scientists, and technical consultants has extensive experience working with the appropriate authorities to reach resolutions regarding the regulatory status of medical devices, as well as experience in successfully defending clients in enforcement actions.  Working closely with the relevant industry associations in the United States and Europe, we keep abreast of the most current policy and regulatory issues affecting the medical devices industry.

Steptoe has experience assisting with the full spectrum of medical device issues, including the following:

  • Representing companies in connection with registration and listing of devices, including assisting with FDA 510(k) pre-market notifications and compliance with the EU Medical Device Directive
  • Providing counsel on Good Manufacturing Practice standards
  • Labeling and Internet marketing
  • Medical device packaging
  • Advising on avoiding product safety liability and defending liability claims
  • Assisting with post-market surveillance issues, including responses to warning letters and other enforcement actions
  • Assisting with establishing the safety and regulatory compliance of antimicrobials and color additives used as components of medical devices