Glossary / FDA

FDA

The US Food and Drug Administration. A connected device that diagnoses or treats can fall under its (and the EU MDR's) medical-device oversight.

Introduced in Chapter 9 — The Data Payload of Tangibles.

Related terms

• Autonomy ladder — A staged scale of how independently a connected device decides and acts, from simple monitoring up to closed-loop control — a way to place a product along the Sense-Decide-Act progression.
• GDPR — The EU's General Data Protection Regulation, governing personal data — with stricter rules (Article 9) for the health and biometric data connected devices increasingly collect.
• HIPAA — The US health-data privacy law that applies once a device's data crosses into medical or health-and-activity territory.
• Predictive maintenance — Using a device's own sensor data to spot a failing machine before it breaks, so it can be serviced early rather than after a costly failure.