Workforce
Training
Medical Device Law, Regulation, and Ethics (IUCRC BRAIN Center Know-How Resource) — A concise, practical series designed to help researchers and partners navigate regulatory pathways, manage risk, and understand policy trends shaping neurotechnology.
Objectives
- Make informed, strategic choices that position your work under favorable regulatory pathways (e.g., FDA PMA / 510(k), De Novo; HIPAA; Common Rule; FDA/IDE).
- Navigate regulatory frameworks affecting innovative biotechnologies: FDA drug & biologic regulations plus relevant EPA, USDA, and consumer protections.
- Understand and manage liability risks.
- Track and influence policy in two key areas:
- Regulation of neurotech software as a medical device after the 21st Century Cures Act of 2016.
- Privacy and access to biospecimens and neurotech data, including research data commons.
Who It’s For
- Faculty, postdocs, and students advancing neurotechnology.
- Industry partners and startups preparing for translation.
- Project leads who interface with compliance, IRB, or legal teams.
Expected Outcomes
- Clear action paths for regulatory next steps and documentation.
- Improved collaboration with IRB/compliance and legal counsel.
- Better risk awareness and integration of policy constraints in planning.
Interested in workshop dates or materials?