"It is essential that we monitor the performance of medical products after they are approved and make sure that we quickly discover any potential problems that might arise," said Andrew C. von Eschenbach, M.D., Acting Commissioner, FDA. "To improve our postmarket data collection at FDA, we are using a total product lifecycle approach to how we look at medical devices and focusing more attention on the kinds of systems and processes we need to have in place to monitor products after they are approved."

During the comment period, FDA wants to learn about the feasibility, utility, benefits and costs associated with developing and implementing a UDI system for medical devices. In addition, the agency wants to hear about various automatic identification technologies, such as bar code and radiofrequency, which could be used with a UDI system. A list of questions as well as what a UDI could look like, are included in the Federal Register notice.


To submit electronic comments, visit www.fda.gov/dockets/ecomments . Written comments may be sent to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD, 20852. Comments must be received by Nov. 9 and include the docket number 2006N-0292.

For more information, visit www.fda.gov/cdrh/ocd/udi/index.html.

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