Medical Devices

Nelson Hardiman represents medical device manufacturers and resellers.   Nelson Hardiman counsels and assists medical device clients with business, regulatory, and strategic challenges, including:

  • Business Transactions
    • Formation of entities and business structure
    • Product clearance and approval
    • Post-market requirements (510(k))
  • Regulatory Defense
    • Defense of FDA investigations
    • Response to FDA warning letters, including development of corrective action plans, remediation plans, and compliance programs
    • Defense of California investigations
  • Compliance
    • FDA compliance counseling
    • Product promotion and advertising.
    • Compliance with California Home Medical Device Retailer (HMDR) requirements
    • HIPAA and state patient data privacy and security requirements
  • Litigation
    • Civil penalty proceedings
    • Product seizures
    • False Claims Act/qui tam whistle-blower litigation defense
    • Payor and reimbursement disputes
    • Disputes regarding exclusive provider contracts
    • Disputes related to transactional misrepresentations
    • Business litigation, including shareholder disputes