advertising and promotion regulations, and reimbursement matters. It offers expertise in product clearance pathways such as 510(k), De Novo, PMA, and Breakthrough Device Designation, including preparation for advisory panels and negotiation with regulators. The team also designs quality system protocols, clinical evidence strategies, and global regulatory dossiers for markets in the U.S., Europe, Canada, and Australia. DuVal & Associates conducts training on FDA law topics like Anti‑Kickback, False Claims Act, and Sunshine Act compliance and supports corporate policy development with real-world oriented counsel.