FDA Visits Foreign Manufacturers of Medium Risk Medical Devices Once Every 27 Yearsby Enterprise Labeling on Aug 11, 2009 • 2:27 pm No Comments
Some days I am very optimistic about the changes afoot to make the Food and Drug Administration a stronger, more powerful place. New rules and regulations on the horizon that will mandatemedical device and healthcare product labeling standards are a very good thing. And, the new Commissioner of the FDA, Margaret Hamburg, in my view speaks her mind. You can see some of that for yourself in this CNSNews item by Matt Cover entitled, “FDA Commissioner Says FDA’s Once-Every-Twelve-Years Pace of Inspecting Foreign Drug Manufacturers is Unacceptable.”
Then some days, due to headlines like that, and the even worse information in the story’s body copy, I realize how far there is yet to travel; how much more there is that remains to be done; and how monumental a task it is. Here, from the story and based on the Government Accountability Office (GAO) are some findings about the intervals of time between the FDA’s inspection of foreign providers of some healthcare items:
Foreign tissue banks are inspected only once every four to five years, and foreign makers of high-risk medical devices such as heart valves and pacemakers once every six years. Makers of medium-risk devices such as hearing aids and electrocardiographs are inspected only once every 27 years, according to the GAO.
Once every 27 years? What’s the point of that? Then again, inspections — even if they could be made all day, everyday, everywhere — are at best a lucky stop-gap method, at worst a bit of a throwback to primitive pre-technology days when walking around and taking a look might have been the only available safeguard. I think the future of the FDA is going to include substantially more, and more sophisticated, systems for insuring product safety and performance and corporate compliance. And, these new ways may just put an end to an inspection tactic that never really worked all that well in the first place.
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