On Monday, September 17, 2012, the Food and Drug Administration (FDA) announced an extension of the comment period on the cost burden estimates for the Unique Device Identifier System Proposed Rule. The proposed rule would implement Section 226 of the Food and Drug Administration Amendments Act (FDAA) of 2007 by establishing regulations requiring medical device manufacturers to label their devices and device packages using a unique device identifier, and to submit information concerning each device to a database known as the Global Unique Device Identification Database (GUDID) that FDA the intends to make public. As FDA summarizes the proposed rule:

This rule would require the label of medical devices and device packages to include a UDI, except where the rule provides for alternative placement of the UDE or provides an exception for a particular device or type of device. Each UDI would have to be provided in a plain-text version and in a form that uses AIDC technology. The UDI would also be required to be directly marked on the device itself for certain categories of devices, such as those that remain in use for extended periods of time and are likely to become separated from their labeling. The rule would require the submission of information concerning each device to a database that FDA intends to make public, to ensure that the UDI can be used to adequately identify the device through its distribution and use.

While the FDA cites many noble reasons for the proposed rule, including reducing medical errors, identifying devices subject to adverse event risks, facilitating corrections to device problems, and where necessary, expedited recalls, the time, effort and money needed by industry to comply with the requirements of the proposed rule are expected to be enormous, and arguably incalculable. Under the terms of the Paperwork Reduction Act, several Executive Orders and the Regulatory Flexibility Act, federal agencies must analyze all costs and benefits of a proposed regulation to avoid regulations that impose excessive costs and burdens without significant countervailing benefits. Here, the FDA has spent numerous years developing this voluminous and far-reaching proposal but has failed to assess its full impact. Indeed, the agency admits, "we are uncertain whether the proposed rule would have a significant economic impact on a substantial number of small entities." The agency is also at a loss to estimate the other important burdens of the proposal, including the estimates of the reporting, recordkeeping and third party disclosure burdens. Thus, the FDA invited comments on the following:

  • Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;
  • The accuracy of FDA's estimate;
  • Ways to enhance the quality, utility and clarity of the information to be collected; and
  • Ways to minimize the burden of collection of information.

When medical device companies evaluated the enormity of the proposal, and the agency's uncertainty about the potential burdens, several companies asked for, and FDA granted, an extension of time for any interested persons to comment on the cost burdens of the proposal. These comments are now due on October 25, 2012. Substantive comments on the proposed rule itself are currently scheduled to be due on November 7, 2012, but it is possible that that date could be extended as well.

The impact of how the FDA implements the proposal could be devastating to medical device companies, especially the thousands of small manufacturers, and the FDA must be made aware of the full scope of the rule's impact.