FDA Issues Proposed Rule for Unique Device Identifiers

Ken Terry | FierceHealthIT | July 5, 2012

Five years after a request from Congress, the Food and Drug Administration (FDA) has finally issued a proposed rule that would mandate the placement of unique device identifiers (UDI) on medical devices. Among other things, the use of UDIs will facilitate the reporting of adverse events related to these devices so that the FDA can more quickly address them and recall devices if necessary.

FDA has been testing UDIs since 2009. In July 2011, the agency sent its UDI proposal to the Office of Management and Budget (OMB), where it was stalled until recently. The new drug user fee legislation includes a provision requiring that FDA set a deadline for releasing the regulations; FDA acknowledged that it issued the notice of proposed rulemaking (NPRM) in response to the passage of that law.

After the NPRM is entered in the Federal Register, there will be a 120-day comment period before FDA writes the final regulations. Health insurance fraud results in enormous losses every year - up to $260 billion, by some estimates. And while technology advances have made it easier for payers to protect their bottom line - these advances are also aiding criminals...