Jennifer J. Hennessy, Associate

FDA Regulatory

Jennifer assists clients in navigating a wide variety of FDA regulatory compliance issues, including:

  • Registering and listing with FDA.
  • Determining whether a particular product is subject to FDA regulation and if so, FDA requirements applicable to the particular product.
  • Guiding clients through the 510(k) clearance process.
  • Advising on advertising and labeling.
  • Drafting/reviewing policies and procedures.
  • Responding to FDA compliance and enforcement activities.
  • Reviewing the overall state of FDA compliance through the due diligence or audit process.