Manufacturers List Their Top Regulatory Issues
Medical Device Link published a wrap-up of major regulatory issues this year as seen from the perspective of device manufacturers. Hot topics include user fees, product safety and FDA culture, uncertainty about FDA leadership, unique device indentifiers, as well as issues specific to companies such as Boston Scientific, Utah Medical or TMJ Implants.
Relationships with the FDA come on top of the manufacturers concerns. They are worried by the increasing reliance on user fees to fund the FDA’s product review activities and wonder how or whether the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) will be renewed by the time it is set to expire in September 2007. (In the meantime and for reference, see this information on ‘07 fee rates published by the FDA in August.) Another source of uncertainty is whether Acting commissioner Andrew von Eschenbach is going to be confirmed by the Senate, where two Senators have been holding it for months.
December 5, 2006 Related topics: Legal & legislative, Medical Devices & Products