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Medical Device Companies

Fenton Law Group represents medical device manufacturers and resellers.   Fenton Law Group 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