FDA issues draft guideline on UDI requirements

Editor's Note

The Food and Drug Administration (FDA) on June 30 issued a draft guideline: “Product Identifier Requirements Under the Drug Supply Chain Security Act−Compliance Policy.”

The draft guidance describes the FDA’s enforcement of requirements related to unique device identification (UDI), specifically those that manufacturers affix or imprint on a package and homogenous case of a product and the standard numerical identifier to verify a product at the package level.

Manufacturers were to begin including UDI on their products on November 27, 2017, but the FDA is delaying enforcement of the  requirement until November 2018 to give manufacturers more time and avoid supply disruptions. Comments on the draft will be received for 60 days.

FDA Issues Draft Guidance: Product Identifier Requirements Under the Drug Supply Chain Security Act - Compliance Policy