The U.S. Food and Drug Administration recently released a proposed rule that will require that most medical devices distributed in the United States carry a unique device identifier (“UDI”). A UDI is a unique code that is designed to allow anyone to identify the model number, lot or batch number, the serial number and/or expiration date for any given medical device. The FDA is also creating a database that will include a standard set of basic identifying elements for each UDI, and will make most of it available to the public. The key elements of the proposed UDI rule are:
- Medical device labels and packaging must include a UDI in a plain-text version and in a form that uses bar codes or other similar technology AIDC technology.
- The UDI would also be required to be directly marked on the device itself for certain categories of devices that are likely to be used for extended periods and become separated from their labels and packaging.
- Information concerning each device must be submitted by industry actors to an FDA database that FDA intends to make public.
- Dates on device labels and packages must be presented in a standard format.
- A UDI must contain two portions:
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- Device Identifier: A code that that identifies the specific version or model of the device and the labeler of the device.
- Production Identifier: Codes that identify variable information, such as a lot or batch, a serial number, an expiration date, or a date of manufacture.
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- Currently exempted devices:
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- Non-prescription devices that are sold at retail establishments, even when such a device is delivered directly to hospitals and other health care facilities.
- Class I devices that FDA has by regulation exempted from the Good Manufacturing Practice requirements.
- The production identifier portion of the UDI would not be required for Class I devices.
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- All UDIs must be issued under a system operated by an FDA-accredited issuing agency. The proposed regulations also describe the rules governing accreditation.
As with any new rule issued by the government, there will be winners and losers. If these requirements will adversely affect your company, we strongly urge you to submit comments to FDA. FDA is required by law to consider every comment it receives when promulgating a new rule and they are accepting comments on this proposed rule through November 7, 2012. Once the window for comments closes, FDA is not required to take any further comments from industry. FDAImports.com has been very successful submitting comments for its clients before and we are ready to work with the medical device industry in preparing and submitting comments on this or any other FDA-related matter.
