FDA's regulatory class for a device product code (see devicePremarketRequirement).
Possible Types
CLASS_I
Class I — the lowest-risk class, and the one most 510(k)-exempt codes sit in.
CLASS_II
Class II — most codes requiring a 510(k).
CLASS_III
Class III — the highest-risk class, where a PMA is normally required.
NOT_CLASSIFIED
Not classified: FDA's own "N", a code predating classification or awaiting it.
UNCLASSIFIED
Unclassified: FDA's own "U".
UNSPECIFIED
A class FDA prints but never defined — the undocumented \"f\" on 51 codes — or none at all. Named rather than guessed at, so the client can show the code without inventing a meaning for it.
Enum.
DeviceClass
FDA's regulatory class for a device product code (see devicePremarketRequirement).
Possible Types
CLASS_I
CLASS_II
CLASS_III
NOT_CLASSIFIED
UNCLASSIFIED
UNSPECIFIED