A mandate that would require medical-device manufacturers to label their products with unique identifiers is expected to be signed into law as a part of a Food and Drug Administration bill currently making its way to President Bushs desk.
The requirement, contained in the Medical Device User Fee and Modernization Act portion of the FDA Amendments Act of 2007, would enable universal tracking and easier location of products in the case of a recall, say supporters of the provision. It would also allow hospitals to better compare products in specific categories.
The FDA would also have the authority to waive the labeling requirement for some manufacturers. One of the complications the FDA will have to face is that medical devices include everything from Band-Aids to very complicated implantable devices, said Joe Pleasant, chairman of the Coalition for Healthcare eStandardsan advocacy organization that has worked with the FDA on the issue. I think what the agency may try to do is say requirements will be different depending on the class of the device.
FDA officials didnt respond to queries about a timeline for developing and implementing an identification system.
Also heading to the presidents desk for reauthorization is the Prescription Drug User Fee Act, which would grant the FDA new authority to take major actions against drugmakers, such as requiring safety studies and ordering label changes, if a problem with a drug arises. The agency would be able to fine companies for violating these new requirements. Companies could also be fined for not completing follow-up research after their drugs have received government approval. -- by Shawn Rhea and Jennifer Lubell
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