FDA Regulatory Support

The FDA Regulatory Support Team provides free consultations to the UCSF community regarding compliance with Food and Drug Administration (FDA) regulations.

If you have questions about how and when FDA regulations apply to your clinical research, please reach out to us.

Consultations can be requested by submitting an FDA Regulatory Support Consultation Request Form.

Alternatively, you may send your FDA related question to UCSF’s FDA Regulatory Support Team at [email protected].

We provide consultations to investigators, study teams, and IRB staff regarding:

  • Eligibility criteria for Investigational New Drug (IND) exemptions
  • IND applications
  • Investigational Device Exemption (IDE) exemptions
  • IDE applications
  • 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.

For additional FDA resources, visit the UCSF Clinical Research Resource HUB.

Contacts

Melanie Hassel, MS, (she/her), Regulatory Specialist, Office of Ethics and Compliance
415-502-3212

Melanie joined the Office of Ethics and Compliance in October 2016 as a Regulatory Specialist, with a focus on FDA regulations. She joined from UC Berkeley after 8 years in various compliance roles. Melanie manages the FDA Regulatory Support and ClinicalTrials.gov Regulatory Support Teams.

Backup for FDA regulatory support matters: Joan Doherty Campbell, JD, Director, Office of Ethics and Compliance. 415-502-2792