US Medical Device Approval Delays and Global SUpply Chain Impact

A New York Times article (February 10, 2011, B1) describes delays in FDA approval of medical devices and their impact on consumers, manufacturers and jobs.  A few key issues (a) FDA approval requires the manufacturer to show the device is safe and effective in treatment while in Europe the device only has to be shown to be safe, (b) Given the long approval times, some companies may prefer to target markets in Europe and Asia and forgo the US market, (c) Device manufacturing and jobs may shift to demand locations, (d) US patients have the option to travel abroad to get treated. But the FDA claims that the European approach may result in failures and thus patient impact as well as costs in the future.   Should the FDA be required to take into account competitive issues as part of its approval process ? Is the slower but more methodical a better approach for FDA or should the standards be changed to be in sync with regulatory approaches in the rest of the world ? Will loss of cutting edge device manufacturing impact the ability to innovate ?

About aviyer2010

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