DEV

Type.

DevicePremarketRequirement

Whether FDA requires a premarket number for a device product code (see devicePremarketRequirement).

Fields

deviceClass

•

DeviceClass

FDA's device class for the product code.

deviceName

•

String

FDA's name for the product code, e.g. "Protector, Dental".

productCode

•

String!

Required

No description

regulationNumber

•

String

21 CFR citation for the classification regulation, e.g. 868.5820.

status

•

DevicePremarketStatus!

Required

What FDA's classification file says the code requires.

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