Download GDSN for the FDA Global Unique Device Identifier Database

GDSN for the FDA Global Unique Device Identifier Database (GUDID)
and effectiveness of Class III medical devices. Class III
devices are those that support or sustain human life, are
of substantial importance in preventing impairment of
human health, or which present a potential,
unreasonable risk of illness or injury. Due to the level of
risk associated with Class III devices, FDA has
determined that general and special controls alone are
insufficient to assure the safety and effectiveness of
class III devices. Therefore, these devices require a
premarket approval (PMA) application under section 515
of the FD&C Act in order to obtain marketing clearance.
Please note that some Class III pre-amendment devices
may require a Class III 510(k). See "Historical
Background2" for additional information.
Data Type
BOOLEAN
GDSN Required
OPTIONAL
Population Guidance (below)
This attribute has a temporary attribute (AVP) in GDSNexemptFromFDAPreMarketAuthorization. It will be deployed into the GDSN Schema in
2016-17 into a final solution.
This Boolean attribute is used to denote if an item is such that is does not require a pre-market
authorization from the FDA (termed an exemption. A value of “TRUE” for this GDSN attribute
signifies that the item has been deemed exempt from needing this type of review. A value of
“FALSE” or a “NULL” value will signify that an authorization is required for the item.
Once published, a 7-day grace period begins. During the grace period, most attributes can
be edited. After the grace period ends on day 8, this attribute can not be changed. Many of
the data elements are locked and can no longer be edited.
Apr 2014, Version 1
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