FDA Draft Rules Following the GHTF’s publication of its UDI guidelines, the FDA is working

FDA Draft Rules

Following the GHTF’s publication of its UDI guidelines, the FDA is working on draft regulation to establish a UDI system in the United States. Draft rules for such an implementation in the world’s largest medical device market significantly would boost adoption rates among other market regulators. Furthermore, since the FDA participates in the GHTF, the U.S. proposal should align adequately with GHTF guidelines.

A draft rule on UDI is expected by the time this article has been published, and one year from the draft rule, a final rule promulgated. At that point, the requirement will be phased in with Class III medical devices first. The FDA will not make recommendations on the bar code system to be used, asserting that the choice between HIBC (Health Industry Bar Code) or GS1 GTIN (Global Trade Item Number) is a business decision.

One interesting comment the FDA has made about the GMDN codes is that the agency is lobbying for these codes to be publically accessible. The European Databank on Medical Devices (Eudamed), which has some functions similar to the UDI system outlined by the GHTF, became compulsory in May 2011.

Eudamed—the European medical device databank—enables European Union Competent Authorities to access data on medical devices, manufacturers, authorized representatives, certifications and other information. Importantly, Eudamed incorporates GMDN codes to support its data exchanges. The UDI is not quite required in Europe yet and hence not captured in Eudamed—though we fully expect UDI to become required, perhaps with the European Union’s recast of the Medical Devices Directives.

In Australia, proposed reforms to the medical device regulatory system also willamend the existing Australian Register of Therapeutic Goods (ARTG) database. The ARTG database is publically available and GMDN codes are required for the ARTG listings. Previously, Australian Manufacturers and Australian Sponsors entered information as device families (for Class IIb and below) without generally specifying details about the device trade names or device models. These reforms will

require ARTG listing entries include product name details.