Michelle C. Jackson

Partner
Jackson Michelle

Michelle Jackson focuses on regulatory counseling related to the development, design, formulation, manufacture, distribution, and promotion of Food and Drug Administration (FDA)-regulated products, including medical devices, foods, dietary supplements, drugs, homeopathic remedies, cosmetics, medical foods, and animal products, as well as in vitro diagnostics. Michelle works with clients from the beginning stages of product development, through product clearance and ultimately advertising and marketing. She also assists clients with transactional due diligence, litigation, and contracts with a regulatory component.

Michelle handles matters involving regulation and enforcement by such state and federal agencies and law enforcement bodies as the FDA, the Federal Trade Commission (FTC), the United States Department of Agriculture (USDA), the Consumer Product Safety Commission (CPSC), state attorneys general, and county district attorneys. She also regularly handles matters involving such self-regulatory bodies as the National Advertising Division of the Council of Better Business Bureaus (NAD).

Michelle has a strong understanding of labeling and marketing requirements for FDA-regulated products, and consumer products more generally. She has assisted with the defense of advertising claims and challenges from regulators, competitors, and consumers, and she understands the expectations of regulators and self-regulatory bodies regarding claim substantiation.

Michelle advises clients on the following topics:

  • Regulatory requirements related to product formulation and design
  • Obtaining product clearance, approval, or permits, such as Investigational Device Exemption (IDE) approval and 510(k) clearance for medical devices
  • Submitting required reports and notifications to FDA, such as medical device reports (MDRs), serious adverse event reports, reports of corrections and removals, new dietary ingredient (NDI) notifications, and reportable food registry (RFR) reports
  • Complying with FDA’s Good Manufacturing Practice (GMP) and Quality System Regulation (QSR) requirements
  • Laboratory certification requirements under the Clinical Laboratory Improvement Amendments (CLIA)
  • CPSC requirements related to child-resistant packaging and labeling for consumer products
  • Product and facility registration and listing obligations
  • Managing FDA inspections and responding to inspectional observations (form FDA 483)
  • Responding to regulatory enforcement actions, such as FDA warning letters, civil investigative demands (CIDs) from the FTC, and subpoenas from the FTC or state attorneys general
  • Product recalls
  • Import and export issues related to FDA-regulated goods, such as import detentions and export certificates

Insights

Credentials
+

Education

  • J.D. cum laude George Mason University School of Law 2004
  • Treasurer, Association for Public Interest Law

    Member, Jessup International Moot Court Team

  • B.S. Biopsychology and Cognitive Science University of Michigan 1999
  • Golden Key National Honor Society

    Psi Chi National Honor Society

Bar Admissions

  • Virginia
  • District of Columbia

Court Admissions

  • U.S. District Court for the Eastern District of Virginia
  • U.S. Court of Appeals for the Fourth Circuit
  • U.S. Supreme Court

Professional Memberships and Activities

  • Member, American Bar Association
  • Member, American Health Lawyers Association
  • Member, Virginia Bar Association

Recognition
+

  • Included in Washington DC Super Lawyers Rising Stars Edition, Food and Drugs, Media and Advertising, 2014, 2016 - 2018