FDA Issues New UDI Draft Guidance

The U.S. Food and Drug Administration (FDA) has issued a new draft guidance on the form and content of unique device identifiers (UDIs) required by the FDA for approval of medical devices to be marketed or sold within the U.S.

Issued in late July, the draft guidance addresses in detail five separate aspects of UDIs, including: 1) UDI forms; 2) disclosure of presence of automatic identification and data capture (AIDC) technology; 3) content of UDI; 4) data delimiters; and 5) the order of the data represented.

Guidance documents are intended to present the Agency’s current view of a given topic and are not binding on either the FDA or the public. Nonetheless, they offer an important perspective that can help manufacturers and importers achieve compliance with FDA requirements.

Read the FDA’s draft guidance on UDI form and content.