The U.S. Food and Drug Administration (FDA) recently announced an amendment to its proposed rule to require most medical devices distributed in the United States to carry a unique device identifier (UDI). According to FDA, the amendment is required by the FDA Safety and Innovation Act (FDA SIA) signed into law in early July of this year.
Under the proposed rule, a UDI is a unique numeric or alphanumeric code that includes a device identifier and a production identifier. The device identifier is specific to a labeler (typically, the manufacturer) and device model. The production identifier includes the current production information for that specific device, such as the lot or batch number, the serial number and/or expiration date.
The proposed rule requires the label of medical devices and device packages to include a UDI, with certain exceptions for alternative placement of the UDI and for particular devices or device types. Each UDI would have to be provided in a plain-text version and in a form that uses bar code, RFID, or similar technology. The UDI would also be required to be directly marked on the device itself for certain categories of devices, such as implantable devices.
The proposed rule originally provided that any final rule would become effective in stages over a period of seven years. One year after publication of the final rule, the label and package for class III medical devices were to bear a UDI. Class II device labels followed two years later, and class I and unclassified labels followed two more years after class II. For devices that must be marked, the start date for class III devices is three years after publication of the final rule, with class II following two years later and class I and unclassified following two more years later.
The recent amendment to the proposed rule bears on the effective date for certain types of devices. As amended by FDA SIA, Section 519(f) of the Food, Drug & Cosmetic Act now requires that FDA “shall implement the final regulations with respect to devices that are implantable, life-saving, and life sustaining not later than 2 years after the regulations are finalized, taking into account patient access to medical devices and therapies.” Accordingly, FDA amended the proposed rule to bring the effective dates into compliance with FDA SIA. The amendment includes the following chart showing the effect of the amendment:
Click here to see Table.
The amendment also includes the following helpful, albeit somewhat complicated, chart summarizing the effective dates of the proposed rule after the amendment:
Click here to see Table.
The FDA announced the amendment after the close of the period for public comment on the proposed rule, and stated that it does not believe the amendment requires it to re-open the comment period.
The full text of the amendment can be found by clicking here.