United States Food and Drug Administration
The FDA is the United States Food and Drug Administration, a federal regulatory agency responsible for protecting public health by regulating a wide range of products that affect food safety, healthcare, and medical technology in the United States.
From a UK or international perspective, the FDA is broadly analogous to a combination of the MHRA, FSA, and parts of DEFRA, but with a single, central authority.
What the FDA Is
The FDA is an agency of the U.S. Department of Health and Human Services (HHS).
Its core mandate is to ensure that regulated products are:
- Safe
- Effective
- Secure
- Properly labelled and manufactured
What the FDA Regulates
The FDA has a very broad remit, including:
Healthcare and Life Sciences
- Medicines and biologics
- Vaccines
- Medical devices (including software as a medical device)
- Clinical trials
- Blood and tissue products
Food and Consumer Products
- Food and beverages
- Dietary supplements
- Food additives
- Infant formula
Other Products
- Cosmetics
- Tobacco products
- Certain veterinary medicines
Notably, the FDA does not regulate healthcare delivery itself—only the products.
FDA and Software / Technology
In modern contexts, the FDA is highly relevant to software teams.
Software as a Medical Device (SaMD)
The FDA regulates software that:
- Diagnoses conditions
- Makes treatment recommendations
- Influences clinical decision-making
This includes:
- AI/ML diagnostic tools
- Clinical decision support systems
- Mobile health apps (in some cases)
Such software must meet FDA requirements before being marketed in the US.
How the FDA Operates
Pre-Market Regulation
Before a product can be sold:
- Evidence of safety and effectiveness is required
- Risk-based classification is applied (Class I–III for devices)
- Approval or clearance is granted (e.g. 510(k), De Novo, PMA)
Post-Market Surveillance
After approval:
- Adverse events must be reported
- Ongoing safety monitoring applies
- Recalls and enforcement actions may occur
FDA vs UK Regulators (High-Level)
| Aspect | FDA (US) | MHRA / UK |
|---|---|---|
| Jurisdiction | United States | United Kingdom |
| Scope | Very broad | More segmented |
| Medical devices | FDA | MHRA |
| Medicines | FDA | MHRA |
| Food | FDA | FSA |
| Enforcement | Centralised | Split across bodies |
The FDA is often seen as more prescriptive and evidence-heavy, particularly for medical devices and software.
Why the FDA Matters Outside the US
Even for UK-based organisations, the FDA matters when:
- Selling healthcare products into the US
- Building software for US healthcare providers
- Supporting clinical trials involving US sites
- Partnering with US life sciences companies
FDA compliance often becomes a commercial requirement, even where UK law also applies.
Common Misunderstandings
-
“FDA approval applies globally” → Incorrect; it applies only in the US.
-
“FDA approval guarantees effectiveness” → No, it demonstrates acceptable safety and efficacy based on evidence.
-
“All health software is FDA regulated” → False; scope depends on risk and intended use.
One-Sentence Summary
The FDA is the United States federal regulator responsible for ensuring the safety, effectiveness, and quality of food, medicines, medical devices, and certain healthcare software sold in the US.