Video: How to Register a Medical Device in the USA (IDE)

Investigational New Drug ( IND ) Registration with US FDA

Video Overview:

To conduct clinical studies in USA, you need to submit an Investigational Device Exemption (IDE) to the Food and Drug Administration or FDA and receive their approval.

How  can GRP Help you with your IDE?

As your partner in USA,  GRP will do the following for you:

Step 1- we will define the classification and the risk of your device

Step 2-  we will identify if your device requires an IDE or not.

Step 3- we will compile the IDE for you, if  

 your device requires an IDE application

Step 4-  We will Submit your IDE Application to the FDA

Step 5- We will respond to FDA queries during the IDE review

Step 6- We will receive FDA  approval for your IDE

Step 7- We will help you start your clinical study in the USA with your new medical device

We have 100% success rate in filing IDEs with US FDA.  GRP, your partner in success, from concept to approval.

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