What is the FDA?
The FDA, or U.S. Food and Drug Administration, is a US government agency responsible for the safety, efficacy and quality of food, medicines, medical devices, cosmetics and other health-related products.
The FDA decides whether a product may enter the US market.
For companies worldwide, this means complying with strict quality and documentation requirements, particularly when exporting to the US.
🎯 What does the FDA do?
| Area of oversight | Examples of regulation |
|---|---|
| Medication | Approval of medicines and vaccines (e.g. via NDA or ANDA) |
| Medical devices | Classification and registration of devices, software and equipment |
| Food & supplements | Requirements for food safety, labelling and traceability |
| Cosmetics | Banning of harmful substances and false claims |
| Digital systems | Validation of software, LIMS, MES, electronic logging |
🔐 Importance for IT/OT systems
The FDA imposes specific requirements on digital systems used in regulated environments, such as:
- FDA 21 CFR Part 11 – Rules for electronic records and electronic signatures
- Validation requirement – Systems must demonstrably function reliably
- Audit trail – All changes to data must be logged
- Access management – Per-user permissions, logging of who does what
- Data Integrity (ALCOA+) – Data must be traceable, accurate and secure
🧭 The FDA and automation
| System | FDA relevance |
|---|---|
| LIMS | Sample registration and release of raw materials or finished products |
| MES | Production records, batch tracking, electronic signatures |
| SCADA | Logging of process values for release or deviation management |
| Historian | Continuous storage of production conditions to support audit trails |
🌍 FDA vs. EU directives
| FDA (US) | EU (e.g. EMA or EU-GMP) |
|---|---|
| Applies to the US market | Applies within the EU |
| FDA 21 CFR Part 11 for e-records | Annex 11 (EU-GMP) for comparable requirements |
| A single central authority | Multiple national agencies under EMA |
📌 In summary
The FDA is the US regulator for food, medicines and medical technology. For IT/OT systems, this means stricter requirements around validation, Logging, data integrity and audit trail — essential when producing for the US market.