Fundamental Rights Impact Assessment

AI systems captured by Article 6 of the EU AI Act because they are safety components of regulated products or listed in Annex III.

The two primary role categories in the AI Act. Providers place systems on the market; deployers put them into use in a professional capacity.

FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.

Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.

Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.

510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.