FDA Won’t Immediately Dispatch Investigators, ‘Guns Blazing,’ To Enforce UDI Regulation

Details about how FDA will likely enforce its upcoming regulation on Unique Device Identification (UDI) are slowly emerging. Specifically, FDA will probably exercise enforcement discretion to give manufacturers and field investigators time to become accustomed to the new UDI requirements. Discretion action might “extend for the first three months or six months after the regulation goes into effect where FDA will not take aggressive enforcement actions,” former FDA official David Elder said. Ultimately, the agency says it will ensure manufacturer compliance to UDI by pursuing a risk-based approach. Meanwhile, FDA appears to have had a change of heart when it comes to prescribing a U.S.-based expiration date format for product labels.