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
