Other stakeholders in commenting on the FDA’s proposed rule also called for a much quicker timeline. Provider alliance Premier Inc., for instance, told the FDA that all classes of devices should have a UDI on the label or package in two years, and direct markings on the devices in three years.
HSCA believes a seven-year wait is too long, “because patient safety outcomes far outweigh any rationale, economic or otherwise, for such a prolonged phase-in,” according to its comment letter recently submitted to FDA. “Furthermore, the proposed phase-in period does not lessen the burden imposed on labelers by the rule, but may in fact increase the burden.” Other recommendations from the association, also mirrored by other stakeholders, include:
* Adopt the international GS1 standards for the UDI system, as GSI is one of the most widely used supply chain standards worldwide;
* Adopt a policy that if a device can be labeled, it must be labeled; and
* Adopt the International Standards Organization standard for the date format labels as yyyy-mm-dd. The rule proposed a format from Arabic numerals, such as Nov. 13, 2012.