Medical Device Classification And Approval Details

Any medical device requires approval from the authorities before it can be marketed in the US

. So, coming up with a new invention isnt enough. You need to get it approved by the Food and Drug Administration (FDA) before you could start using it. There are a few things you need to be aware of before you get involved in the process.

An idea transformed into an invention is just the beginning in the medical device development process. Classification of the device, applying for the approval and working towards achieving it are steps of the process. Knowing a little more about the details is sure to be helpful.

Classification of medical device

Medical devices are usually categorized into the following classifications:

Class I These devices are simple in design and are non-life sustaining. Thus their failure does not endanger life. Examples include elastic bandages, examination gloves, hand-held dental and surgical instruments, etc.

Class II These are more complicated in design and function than the Class I devices. But they are also non-life sustaining; thus no risk to life in case of failure. Some of these are x-ray machines, wheelchairs that operate on power, surgical needles, and so on.

Class III These devices are used for life support. As these are life-sustaining their failure poses risk to life. This category includes devices like heart valves, implanted cerebral stimulators, etc.

Steps in the approval process

The marketing application needs to be approved by the FDA before you could start selling it. In case the device classifies in the first two categories, check whether you need to apply or not. If yes, you have to follow various steps to get it approved. If not, all you need to do is follow certain quality standards in the manufacturing process, properly package and label the product, and get registration with the FDA as the manufacturer.

What if your device needs to get approved? After the completion of the medical device development you need to run a check on whether it is an up-gradation of another device. If your device is effective and safe and it could be proved that it is of similar nature to another already approved device you can utilize the Premarket Submission process termed as 510(k).

The marketing application would be subject to Premarket Approval in case it doesnt adhere to the 510(k). In this method, you need to apply for an approval. In the beginning you would get what is termed as Investigational Device Exemption. This would give you the opportunity to conduct research on the two important aspects of the medical device its effectiveness and the safety.

Only after you have collected enough data to support your claim that the medical device is qualitatively better than others, safe to use and effectively performs what it is supposed to, you can go ahead and ask for the approval.

by: Ashley Smith

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