Politico: FDA Efforts to Create International Uniform Device Code Stalled by OMB
Politico is reporting that efforts spearheaded by Congress five years ago to create a worldwide uniform device identification (UDI) system have stalled out in the regulatory process "for reasons that are unclear."
The unique identification system, mandated in 2007 under the Food and Drug Administration Amendments Act (FDAAA), was intended to standardize how medical devices are tracked. Congress envisioned a simple system similar to how groceries are scanned at a checkout counter.
The US Food and Drug Administration (FDA) created the regulations for such a system in 2011, but Politico reports that the proposal has been stuck at the Office of Management and Budget (OMB) ever since. Politico's efforts to get an explanation for the delay have been met with silence, as have requests from other hospital groups.
The delay in OMB approval risks further divergence in standards, according to medical device industry trade group AdvaMed. "If the FDA were to publish their proposed rule tomorrow, other countries would know what they had to work with," said Jeff Secunda, vice president for technology and regulatory affairs at AdvaMed in a statement to Politico.