Medical Device Should Pass FDA Regulations

A medical device is defined by the World Health Organization as any instrument or apparatus (or even software) intended for diagnosis, treatment, and alleviation of any disease or injury. Medical devices are subject to regulation both by the U.S. Food and Drug Administration and the World Health Organization.

Medical devices can range from sophisticated pacemakers and laser surgery equipment to simple tongue compressors. These are equipment for medical use intended to affect our bodily functions without being ingested or metabolized.

The FDA has categorized medical devices into three; class I, or devices which present the least potential of harm to the user (e.g. bandages); class II, or devices which are designed to perform as indicated (e.g. pregnancy test kits and wheelchairs); and class III, or devices which are specifically designed to sustain human life (e.g. implantable pacemakers)

Currently, the U.S. is and remains to be the largest medical device market worldwide, with over 6,500 medical device companies and a market size about $110 billion which is expected to grow by as much as $133 billion by 2016. Medical devices still have to be regulated to ensure the general well-being and safety of patients who use them. Make sure that any medical device that you buy is FDA-approved.

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