Predicate Device
/ˈprɛdɪkət dɪˈvaɪs/
Definitions
- (n.) A medical device that forms the basis of a significant portion of a premarket submission by serving as a predicate for demonstrating substantial equivalence.
The FDA reviewed the new device by comparing it to a legally marketed predicate device.
Forms
- predicate device
- predicate devices
Related terms
See also
Commentary
In regulatory law, a predicate device is crucial for 510(k) premarket submissions to establish that a new device is substantially equivalent to an existing legally marketed device, facilitating FDA clearance.
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