FDA's premarket requirement for a device product code (see devicePremarketRequirement).
Possible Types
EXEMPT
510(k) exempt — 2,638 of the 7,088 product codes. No premarket number exists for any of them, so PM# has no answer and should not be asked.
REQUIRED_510K
Requires premarket notification — a 510(k) number, the K-prefixed answer PM# expects most often. The number is guaranteed to exist, so PM# is worth insisting on.
REQUIRED_PMA
Requires premarket approval — a PMA number, P-prefixed. As with a 510(k), the number is guaranteed to exist and PM# is worth insisting on.
UNSPECIFIED
FDA's submission type is one of the rare mixed ones (3, 6, 7, 8) or blank, so it settles nothing either way — ask PM# without insisting on it.
Enum.
DevicePremarketStatus
FDA's premarket requirement for a device product code (see devicePremarketRequirement).
Possible Types
EXEMPT
REQUIRED_510K
REQUIRED_PMA
UNSPECIFIED