Whether a premarket number can exist for an FDA device product code, from FDA's classification file. 510(k)-exempt codes have no premarket number to give, so PM# should not be asked on them at all; on a code that requires 510(k) or PMA the answer is guaranteed to exist and is worth insisting on. Null when the product code is not in FDA's classification file.
Query.
devicePremarketRequirement
Whether a premarket number can exist for an FDA device product code, from FDA's classification file. 510(k)-exempt codes have no premarket number to give, so PM# should not be asked on them at all; on a code that requires 510(k) or PMA the answer is guaranteed to exist and is worth insisting on. Null when the product code is not in FDA's classification file.
Arguments
productCode
String!
Required
Returns:
DevicePremarketRequirement
type Query { devicePremarketRequirement(productCode: String!): DevicePremarketRequirement }Was this page helpful?