FDA Regulations for Online Medical Device Sales In America

With the rapid growth of online medical device sales it is now the responsibility of the FDA to ensure that consumers have quick and easy access to all new and advanced devices and instruments and also to prevent all potentially unsafe and faulty devices from entering or remaining in the market. Naturally the regulations for online medical devices, surgical and operating room instruments sales in America are extremely complex. An extremely wide variety of items are categorized as medical devices by the FDA those include everything from simple tongue depressions to extremely complex life sustaining heart valves.

The FDA is responsible for protecting public health in America by overseeing all surgery and medical instruments and all medical product manufacturers in the country are required to register their facilities with the agency and also list all devices manufactured by them along with following the general control requirements. All devices those are listed with the FDA are then classified according to the level of risk that they pose for the users. Manufacturers are required to either conduct clinical studies for submitting a premarket review to the agency or provide a notification demonstrating that the device is substantially equivalent to a product that has been already approved by the FDA to make the device available in the market. Once a device like a medical camera or anything else is approved by the FDA for marketing, the manufacturers must comply with all regulations related manufacturing labeling, surveillance, adverse effect reporting etc.

Any medical device manufacturer willing to sell their products in America must comply with the strict FDA regulations, for even minute problems with a device can have serious consequences for the patients and can even be life threatening at times. In spite of such strict norms thousands of deaths are reported in America every year due to device related injuries or malfunctioning of medical devices and this high number of deaths makes it all the more important to buy best quality devices only from legitimate online medical equipment selling companies. The medical technology industry is a vibrant and important contributor to the US economy and includes sub-industries like diagnostic, drug manufacturing and delivery, analytic science, medical devices etc.

There is no denying the fact that even minute problems with operating room instruments and devices like pacemakers, defibrillators etc can have serious consequences on the health of a patient causing serious injuries and even deaths. When it comes to buying refurbished surgical instruments online you are actually required to consider a number of different factors but understanding what refurbished actually means is probably the first thing that you required to do. Refurbishment of medical devices is a process that intends upon bringing a product back to its original manufactured condition and the process includes steps like inspection and replacement of old and worn out parts and their recalibration, cosmetic maintenance of the device that provides it with an exact new like look and finally confirming that the equipment is in perfect working condition with uncompromised efficiency and accuracy. As a matter of fact refurbished medical instruments can cost anything between 30 to 70 percent less expensive than new branded equipments and this can allow the facilities to offer best quality healthcare services against lower prices. In order to know more about online medical device and surgical equipments sales, visit Medical Device Store website at http://www.medicaldevicestore.com/.

About The Author

Neil Jackson is a Medical Device Specialist who has been in the industry for more than a decade now. He has been regularly following the leading medical device companies across the globe, especially the in the U.S. He has also authored quite a few articles in medical Journals and loves to share his vast experience and knowledge.