Medical Device Law, Regulation, and ethics (IUCRC BRAIN Center Know-How Resource)
Objectives:
Make informed, strategic choices that position their work under the most favorable regulatory pathways (FDA PMA/510(K) de novo/other/HIPAA/Common Rule/FDA/IDE)
Navigate the broader regulatory frameworks affecting innovative biotechnologies: FDA drug and biologic regulations + relevant EPA, USDA, and consumer protections
Understand and manage your liability risks
Affect ongoing policy setting on two crucial issues:
- Regulation of neurotech software as a medical device after the 21st Century Cures Act of 2016
- Privacy and access to biospecimens and neurotech data and the creation of neurotech research data commons
Research Team
Arizona State University, the University of Houston, University of Maryland, Baltimore County, Georgia Tech, Universidad Miguel Hernández de Elche, Spain, and Tecnológico de Monterrey, Mexico, have a unique concentration of PIs who have the resources and expertise to design, develop, and test innovative neurotechnologies that can effectively transform the lives of physically and cognitively impaired individuals.
