by Joel Harrison
6. September 2011 11:26
It has been announced that the American Food and Drug Administration (FDA) is planning to change the method in which the agency evaluates and approves devices used to manufacture contact lenses. It will be the first such change in decades.
According to an Institute of Medicine panel, the current methods used in the process of approving numerous medical devices may not consider the safety of patients completely. The representatives of the institute stated that there is a need for reworking the way the American government regulates the production of medical devices, which is a huge industry worth over £200 billion.
The director of the FDA for medical devices, Jeffrey Shuren, stated that the FDA is not going to eliminate the 510(k) process (granting fast approval), but the agency is open to suggestions and will consider alternative approaches.
In addition, David Challoner, who used to be the vice-president of health affairs at the University of Florida, said that changes are necessary as there are completely new technologies and materials that make the current methods less effective.
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