Brynn Stanley
Associate Attorney

• FDA regulatory strategy, including submission strategy and lifecycle counseling
• Enforcement response (FDA, DOJ, CMS, and OIG)
• Promotional and educational activities
• Compliance with healthcare provider interactions (AKS, FCA, Stark, FCPA, AdvaMed, PhRMA, OIG guidance, Sunshine Act, and state and municipal analogs)
• Quality Management System design, audits, and remediation
• Product recalls, corrections and removals, CAPA, health hazard evaluations, and risk management
• New product development and design change management
• Quality Agreements, Supply Agreements, Product Development and Manufacturing Agreements
• US and global clinical trials
• Regulatory and compliance diligence in transactions
• Privacy and HIPAA compliance

• Counsels clients on supply chain planning and management, including supplier assessments, audits, and quality agreements.
• Performs Quality Management System (QMS) assessments and audits and assists clients on QMS design and implementation.
• Advises clients on new product development and design change management, including Program Management, development of the Risk Management File, the Design and Development File, and FDA regulatory submissions.
• Assists clients with product recalls, corrections and removals, corrective and preventive actions (CAPA), and health hazard evaluations.
• Advises clients on US and global clinical trials, including drafting and negotiating clinical trial agreements, informed consent forms and patient authorizations.
• Reviews product labeling and product claims including food packaging, instructions for use and patient guides, dietary supplements, and cosmetics.

• 15 years in engineering and technical roles before practicing law
• FDA and healthcare attorney with in-company secondment experience
• Deep experience advising on healthcare provider interactions and enforcement risk (AKS, FCA, Stark, FCPA, OIG)
• Regularly handles matters involving FDA, DOJ, CMS, and OIG
• Works directly with in-house legal, regulatory and quality teams, boards, and executives
• Focused on solving regulatory problems without disrupting business operations

• Adjunct Professor of Law, Mitchell Hamline School of Law - Drug and Device Law
• FDA Publishes First Draft Guidance for Clinical Trials with Psychedelic Drugs
• FDA’s New Draft Guidance on Cybersecurity
• Wishful thinking by FDA that COVID-19 May Be Coming to an End?

• J.D., Mitchell Hamline School of Law
• B.BmE., University of Minnesota

• Member, Minnesota State Bar Association - Food, Drug and Device Law Section
• Member, Minnesota State Bar Association - Health Law Section
• ISO 13485:2003 Lead Auditor (TPECS)

Outside of her legal practice, Brynn is an avid gardener who grows, shows, and judges dahlias. She is also actively involved in animal rescue, volunteering with local organizations and fostering dogs, often helping prepare them for adoption and placement in permanent homes.

• CDS Software Final Guidance Carries Real Consequences for Manufacturers
• FDA’s Revised QMSR Modernizes Device Quality Regulation
• What FDA’s TEMPO Pilot and CMS’s ACCESS Model Mean for Medical Device Manufacturers