Medical Device Company Lawyers

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