The FDA Regulatory Support Team within the Office of Ethics and Compliance (OEC) provides free consultations to the UCSF research community regarding compliance with Food and Drug Administration (FDA) regulations.
We provide consultations to investigators, study teams, and Institutional Review Board (IRB) staff regarding:
- Eligibility criteria for Investigational New Drug (IND) applications and exemptions
- Eligibility criteria for Investigational Device Exemption (IDE) applications and exemptions
- In-Vitro Diagnostics (IVD) and Assays
- Mobile Medical Applications
- Artificial Intelligence (AI)/Machine Learning Algorithms
- Clinical Decision Support Tools
- Related IRB determinations in the context of clinical research
- FDA inspection support.
Request a Consultation
To request a consultation, please submit a completed FDA Regulatory Support Consultation Request Form.
FDA Regulatory Support Partners
Compliance with FDA regulations is a team effort across many different stakeholders. Charts outlining roles and responsibilities of the various stakeholders are provided below.
Roles and Responsibilities for Compliance with FDA Regulations Pertaining to Clinical Research
Roles and Responsibilities of the Various Stakeholders during an FDA Audit of Clinical Research
Resources
Resources, including guidance, policies and procedures related to FDA regulations applicable to clinical research, are available at the UCSF Clinical Research Resource HUB’s Regulatory page.
Key Contacts
You may send FDA regulatory compliance related questions to UCSF’s FDA Regulatory Support Team at [email protected].
- Melanie Hassel, (she/her) Regulatory Specialist, 415-502-3212; [email protected]
- Joan Doherty Campbell, Director, Office of Ethics and Compliance; 415-502-2792