The United States of America is the largest medical device market in the world. A population’s age is a good indicator of how high the need for medical devices will be in the coming years. As the United States’ “Baby Boom” population (those born in the years 1946-1964) continues to age, the medical market is projected to steadily increase. Coupled with the fact that those ages 15-64 years make up 66% of the nation’s population, the United States’ status as the largest medical device market in the world is not expected to change anytime soon.
Medical devices are part of your everyday life and you are likely using many more than you realize. A medical device can be anything from a thermometer to a pace maker. To be marketed or distributed in The United States a medical device must be registered with the FDA.
While the requirements for a thermometer and a pace maker are different, the requirements for all classes of medical devices are regulated by the FDA. The Food and Drug Administration (FDA), the governing body for medical devices in The States, has varying degrees of requirements and approvals in place for the manufacturing and distribution of medical devices in The States. The first step is registering your medical device. Depending on its classification, there are additional requirements for taking your medical device to the market. In addition to the initial steps of registering a medical device, there are also requirements for maintaining your registrations, and protocols in place for what to do in the event of a recall, or reclassification.
If you or your company are planning to introduce a medical device into the American market or are navigating the ongoing requirements of the FDA, Medpoint can help. The ongoing updates and protocols can be daunting to navigate. Medpoint can also help if your device is reclassified or if you need help with a recall or FDA warning letter. Our consultants are well-versed in the requirements and protocols stipulated by the FDA and have a wide base of experience and knowledge in the multiple facets of obtaining and upkeeping certification with the FDA.
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