FDA 483 OBSERVATION · #819 OF 1,000 MOST-CITED
GUDID Information required for unique device identification.
FDA cited this observation 23 times across 22 firms in recent inspections. Below: how it breaks down by program area and fiscal year, and real examples of how FDA worded it on Form FDA 483.
How FDA worded it — real examples
The correct unique device identifier (UDI) information regarding device identifier portion of the UDI assigned to the version or model, the device identifier that was previously assigned to the version or model, permanent marking requirements, proprietary, trade, or brand name of the device as it appears on the label, version or model or similar reference that appears on the label of the device, sterility of the device, natural rubber latex contained in the device, safety concerning exposure to magnetic resonance tomography while using the device, size of the particular version or model given the device is available in more than one size, the type of production identifiers that appears on the label of the device, the FDA premarket submission number of a cleared or approved device, a statement that FDA has by regulation exempted the device from premarket notification, the Global Medical Device Nomenclature (GMDN) term or code for the device and the total number of individual devices contained in the device package was not provided to the FDA via the Global Unique Device Identification Database (GUDID).
The correct unique device identifier (UDI) information regarding device identifier portion of the UDI assigned to the version or model was not provided to the FDA via the Global Unique Device Identification Database (GUDID).
The correct unique device identifier (UDI) information regarding device identifier portion of the UDI assigned to the version or model was not provided to the FDA via the Global Unique Device Identification Database (GUDID).
The correct unique device identifier (UDI) information regarding was not provided to the FDA via the Global Unique Device Identification Database (GUDID).
The correct unique device identifier (UDI) information regarding device identifier portion of the UDI assigned to the version or model, proprietary, trade, or brand name of the device as it appears on the label, version or model or similar reference that appears on the label of the device and the type of production identifiers that appears on the label of the device was not provided to the FDA via the Global Unique Device Identification Database (GUDID).
The correct unique device identifier (UDI) information regarding device identifier portion of the UDI assigned to the version or model was not provided to the FDA via the Global Unique Device Identification Database (GUDID).
Related SPEQ references
Where to read the requirements behind this observation area on SPEQ. These are SPEQ's topic and audience pages — not an FDA classification of the citation.
Examples are a representative sample of FDA's published inspection observations. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.