Thanks to the ePackage Newsletter from Pharmaceutical & Medical Packaging News, and the reporting of Senior Editor David Vaczek, we’ve got a timely perspective on what the FDA is looking at for unique device identification (UDI) solutions. The look-ahead comes from Jay Crowley, senior advisor for patient safety, FDA’s Center for Devices and Radiological Health (CDRH).
You should read the whole item if you want to know more about timetables and other specifics. But here are the three most important paragraphs in my opinion:
Manufacturers will likely be able to choose between GS1’s GTIN and HIBCC’s HIBC data formats, which many device manufacturers currently use. Device makers would assign the item reference number (GSI) or product identifier (HIBCC) for creating the device ID. The ID incorporates labeler codes obtained from GS1 or HIBCC.
NDC and NHRIC numbers are not favored. “The NDC is a U.S.-only system. As part of its program for improving the NDC system, FDA is phasing out the NHRIC.
“We are working toward an internationally harmonized system with numbers maintained outside of the U.S. regulatory scope. If manufacturers follow the GTIN or HIBCC rules, the theory is that the numbers will always be unique,” Crowley says.