On On July 3, 2012, the U.S. Food and Drug Administration (“FDA”) announced its intention to require most medical devices in the United States to bear a Unique Device Identifier (“UDI”). According to the FDA, this UDI system could potentially improve availability and quality of information in medical device adverse event reporting and in the event of product recalls. Under the text of the Proposed Rule, published in the Federal Register on July 10, 2012, a UDI will include a unique numeric or alphanumeric code identifying the specific device model and a production identifier, containing the current production information for the device. The FDA will be seeking comments on the Proposed Rule until November 7, 2012. Comments to the proposal may be made here.
Like most regulations pertaining to medical devices, the FDA intends to implement the new UDI system using a risk-based approach, meaning that the focus is on devices with the highest risk, i.e., Class III medical devices, and the Agency will exempt low risk, or Class I, devices from some or all of the new regulatory requirements. Similarly, the FDA currently does not require notification prior to the initial distribution of many low risk devices and exempts these devices from various other regulatory requirements. For more information about the UDI system or medical device regulation generally, please contact us at [email protected].
