US (FDA)

Covers all labeling requirements for medical devices including labels affixed to the device and all descriptive and informational literature that accompanies it.

Mandatory reporting for incidents where a device may have caused or contributed to death or serious injury. Applies to manufacturers, importers, and device user facilities.

Requires a 510(k) submission before commercial distribution of a device, demonstrating substantial equivalence to a legally marketed predicate device.

Governs the most stringent FDA device pathway, required for Class III high-risk devices. Requires valid scientific evidence of safety and effectiveness, including clinical data.

Allows investigational devices to be used in clinical studies to collect safety and effectiveness data in support of a PMA or 510(k) submission.

Governs methods, facilities and controls used in design, manufacture, packaging, labelling and servicing of finished devices. Effective February 2026, incorporates ISO 13485:2016 by reference.

The foundational US law authorizing FDA to regulate medical devices. Sections 513–520 govern device classification, premarket review, postmarket requirements, and enforcement.

Requires domestic and foreign manufacturers to register with FDA and list their devices annually. Foreign manufacturers must designate a US Agent.