FDA Launches Second Trial Balloon to ID Medical Devices
In a notice to be published in tomorrow’s Federal Register (see this preview in PDF format), the FDA is seeking public comment for the next three months about the use of unique device identifiers (UDIs) on medical devices. Daniel Schultz, M.D., Director, Center for Devices and Radiological Health, stated that:
“[m]uch like the bar code rule for drugs and biological products, unique identifiers for medical devices could have many potential benefits for improving the quality of care for patients. A unique device identifier system could have broad applications in reducing medical errors, facilitating device recalls, improving medical device adverse event reporting and encouraging cost effectiveness by improving delivery and supply chain efficiency.”
Two reports commissioned by the agency from third-party experts identified several potential benefits of a UDI system, including identifying incompatibility with devices or potential allergic reactions. 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. Comments will be taken my postal mail or online here (docket 2006N-0292 is not yet open for comments as we write these lines).
The New York Times reminds its readers that the FDA first floated a similar idea as an extension of the identification of drugs introduced two years ago. On February 26, 2004, rule 69FR 9120 also known as the “bar code rule” made the use of bar codes compulsory on certain human drug and biological products with thorough implementation by all parties by April 26, 2006 (see 21CFR201.25 and 610.67 for the exact requirements in the Code of Federal Regulations, as well as this guidance Q&A). Device makers argued they are a diversified bunch and that the FDA proposal was impractical to implement. The Star Tribune quotes several industry executives and representatives who seem to prefer a voluntary approach.
August 10, 2006 Related topics: Legal & legislative, Medical Devices & Products