Medical Device Company Lawyers

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