| Any medical device requires approval from the | | | | Steps in the approval process |
| authorities before it can be marketed in the US. So, | | | | The marketing application needs to be approved by |
| coming up with a new invention isn't enough. You | | | | the FDA before you could start selling it. In case the |
| need to get it approved by the Food and Drug | | | | device classifies in the first two categories, check |
| Administration (FDA) before you could start using it. | | | | whether you need to apply or not. If yes, you have |
| There are a few things you need to be aware of | | | | to follow various steps to get it approved. If not, all |
| before you get involved in the process. | | | | you need to do is follow certain quality standards in |
| An idea transformed into an invention is just the | | | | the manufacturing process, properly package and |
| beginning in the medical device development process. | | | | label the product, and get registration with the FDA |
| Classification of the device, applying for the approval | | | | as the manufacturer. |
| and working towards achieving it are steps of the | | | | What if your device needs to get approved? After |
| process. Knowing a little more about the details is | | | | the completion of the medical device development |
| sure to be helpful. | | | | you need to run a check on whether it is an |
| Classification of medical device | | | | up-gradation of another device. If your device is |
| Medical devices are usually categorized into the | | | | effective and safe and it could be proved that it is of |
| following classifications: | | | | similar nature to another already approved device |
| Class I – These devices are simple in design and | | | | you can utilize the Premarket Submission process |
| are non-life sustaining. Thus their failure does not | | | | termed as 510(k). |
| endanger life. Examples include elastic bandages, | | | | The marketing application would be subject to |
| examination gloves, hand-held dental and surgical | | | | Premarket Approval in case it doesn't adhere to the |
| instruments, etc. | | | | 510(k). In this method, you need to apply for an |
| Class II – These are more complicated in design | | | | approval. In the beginning you would get what is |
| and function than the Class I devices. But they are | | | | termed as Investigational Device Exemption. This |
| also non-life sustaining; thus no risk to life in case of | | | | would give you the opportunity to conduct research |
| failure. Some of these are x-ray machines, | | | | on the two important aspects of the medical device |
| wheelchairs that operate on power, surgical needles, | | | | – its effectiveness and the safety. |
| and so on. | | | | Only after you have collected enough data to |
| Class III – These devices are used for life | | | | support your claim that the medical device is |
| support. As these are life-sustaining their failure poses | | | | qualitatively better than others, safe to use and |
| risk to life. This category includes devices like heart | | | | effectively performs what it is supposed to, you can |
| valves, implanted cerebral stimulators, etc. | | | | go ahead and ask for the approval. |