Glossary
De Novo authorization
The FDA's route for a new kind of lower-risk device with nothing like it on the market.
When a medical device is new and there is nothing similar to compare it with, the maker can ask the FDA for De Novo authorization. Once granted, the device can be sold for the authorized uses and becomes a comparison point for later devices.
More words
Robotaxi · Safety driver · Safety monitor · Remote operator · Teleoperation · Humanoid robot · Pilot · Company-reported · FDA clearance (510(k)) · Part 135 certificate · Levels of driving automation · Cobot · Exoskeleton