Food and Drug Administration (FDA)

The Food and Drug Administration (FDA) is the agency of the US Department of Health and Human Services responsible for protecting public health by regulating human and veterinary drugs, biological products, medical devices, food, cosmetics and tobacco. Its centres most relevant to life sciences are CDER (drugs), CBER (biologics, including cell and gene therapies) and CDRH (devices and diagnostics).

In clinical research the FDA authorises trials through the IND process (21 CFR Part 312) and the Investigational Device Exemption (21 CFR Part 812), sets human subject protection rules (21 CFR Parts 50 and 56, alongside the Common Rule), defines electronic records and signatures requirements (21 CFR Part 11), conducts Bioresearch Monitoring inspections of sponsors, CROs and sites worldwide, and reviews device submissions such as the 510(k) and PMA. It also issues guidance on AI-enabled devices, decentralised trials, real-world evidence and diversity action plans.

The FDA is not a "data protection authority" but it is a major recipient of pseudonymised individual patient data from European trials, through SDTM and ADaM submissions and inspections. The United States has no adequacy decision covering federal agencies, so these disclosures are generally justified under Art. 49(1)(d) GDPR (important reasons of public interest) and must be described in the informed consent form. FDA inspectors' access to source documents at EU sites should likewise be anticipated in the clinical trial agreement and participant information.