Medical Device
Advancing Innovation
Partnering on the Pathway
Gardner Law provides comprehensive support for medical device companies throughout the product lifecycle, guiding clients from research and development through post-market compliance. This includes advising on regulatory landscapes such as FDA regulations in the United States or CE marking requirements in the European Union, drafting contracts with suppliers and manufacturers, and strategizing risk management and product development. Throughout clinical trials and regulatory submissions, Gardner Law ensures compliance with requirements such as patient consent and data privacy, while post-market, they assist in maintaining compliance, managing adverse events, navigating continued compliant manufacturing and operations, and litigation counsel and resolving enforcement actions. Ultimately, their services contribute to the success of medical device innovation and commercialization.
Representative Matters Include:
- FDA regulatory strategy and submission support for 510(k) Premarket Notifications, Premarket Approvals, Emergency Use Authorization (EUA), Humanitarian Device Exemptions (HDE), Investigations Device Exemption (IDE), Pre-IDEs, De Novo, Annual Reports, PMA Supplements, Requests for Designation (513(g))
- Support with requesting and preparing for Q-Submissions (e.g., Pre-Submission, Submission Issue Requests (SIR))
- Regulatory assessments and opinions on device classification and regulatory pathways
- Strategy and preparation for FDA meetings and communications
- OIG Advisory Opinion Request
- Research and clinical study support, including drafting and negotiating Clinical Trial Agreements, subject recruitment practices
- State medical device licensing requirements and filing
- Compliance policies and procedures
- Setting up a compliance program and assessing commercial activities to comply with the AdvaMed Code and industry best practices
- Compliance audits, investigations, and training
- Reviewing website and mobile apps, terms of use
- Privacy and cybersecurity audits
- Privacy and cybersecurity policies and procedures
- Privacy and security incidents
- Privacy officer and data protection officer services
- Privacy training for organizations, including case coverage and complaint handling
- FDA Quality Management System requirements, risk management, design controls, complaint handling, CAPAs
- Review and advising on Business Associate Agreements (BAAs)
- Recalls, corrections, and removals
- Litigation and enforcement actions
- Product liability strategy and counseling
- Advertising and promotional review
- Due diligence review for FDA-regulated companies
- Transparency reporting to federal (“Sunshine Act”), state, and municipal authorities
- Counseling on patient support programs