Representative Experience

  • Advised medical device clients on submissions of 510(k) premarket notifications, premarket approval applications, de novo and 513(g) requests to FDA; represented clients in meetings with 510(k) reviewers and submitted responses to requests for additional information
  • Drafted several risk analyses providing guidance regarding the regulation of stem cell research and procedures conducted in the United States and abroad and the implications for U.S. business operations
  • Reviewed and revised several drug and device clients’ advertising (website, radio, and television commercials) for compliance with the FDCA and the FTC Act; collaborated with their advertising teams on revisions to content to maximize product marketability and compliance with regulations
  • Drafted privacy policies, terms of use, and return policies for dietary supplement and medical device companies; ensured that policies were consistent with business objectives, priorities, and policies
  • Provided regulatory guidance on HIPAA and the Health Information Technology for Economic and Clinical Health (HITECH) Act to a client engaged in class-action litigation regarding electronic health records software
  • Drafted a petition to FDA requesting the exercise of market discipline regarding its enforcement of adipose-derived stem cells; FDA thereafter issued a warning letter to a competitor
  • Revised and drafted corporate documents for the sale and purchase of a dental corporation, including articles of incorporation, physician agreements, and management services agreements
  • Assisted in the representation of a nursing home to recover denied Medicare reimbursement claims; drafted and  filed over 22 motions for reconsideration and subsequent appeals