Laser-Guided Precision

Clear Focus

Gardner Law provides legal advice and support services to clinical laboratories. We help our clients understand and comply with laws, regulations, and standards. Our deep experience and focused approach in identifying and addressing the core issues is what distinguishes us in the industry. Gardner Law brings years of experience in reimbursement, privacy and cybersecurity, health care compliance, litigation, and regulatory matters to tackle your toughest problems with laser-guided precision.

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
  • Laboratory Services Agreements
  • CLIA compliance
  • Counseling on patient support programs
  • Research and clinical study support, including drafting and negotiating Clinical Trial Agreements, subject recruitment practices
  • State medical device and pharmaceutical manufacturing licensing
  • 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
  • Assisting laboratories building HIPAA compliance programs as a business associate or covered entity
  • 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