FDA Issues Proposed Rule on Medical Device Labeling
On July 10, the Food and Drug Administration (FDA) released a proposed ruleon medical device labeling. The FDA promulgated the rule to “substantially reduce existing obstacles” to medical device identification. Among other benefits the FDA recognized, the rule is intended to reduce medical errors due to misidentification or incorrect medical device use and improve reporting of adverse events caused by devices.
Under the proposed rule, medical devices are required to have a unique device identifier (UDI) with a standard date format (e.g., JAN 1, 2012). The UDI will also identify the specific version or model of the device, the labeler of the device, and a production identifier, such as a lot or batch number, a serial number, an expiration date, or a manufacture date. The UDI must be in two forms: easily-readable plain-text and automatic identification and data capture (AIDC) technology format.
Subject to limited exceptions, every medical device will require a UDI. Excepted medical devices include (but are not limited to) non-prescription devices sold at retail establishments; a device used solely for research, teaching, or chemical analysis, and not intended for any clinical use; and exported medical devices. The proposed rule also has a procedure to request an exception from or alternative to the UDI requirements.
The FDA plans to phase in the UDI requirement. Class III medical devices and devices licensed under the Public Health Service Act must be labeled within one year after publication of the UDI final rule. Class II medical devices must be labeled within three years. Class I medical devices must be labeled within five years. Finally, the proposed rule contains reporting requirements, including requiring “labelers” to submit data to the Global Unique Device Identification Database.
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