11 Steps in the US FDA Medical Device Approval Process | US FDA Registration Process for Medical Devices India

US FDA Registration Process for Medical Devices

Eurotech And Meddevices Certification Body Providing US FDA Certification and Registration service in India. If your client Demanding for US FDA Certification Registration, you can feel free to contact us.

All The Manufacturers, Traders, Suppliers, Exporters companies planning to sell a Medical Devices in the United States of America need to register their product with the US FDA Registration. Most Class 1 devices can be self-registered but most Class 2 devices require a 510(k) submission. For Class 3 devices, a Pre-Market submission is needed. The steps below provide a brief overview of how the PMA & (Food and Drug Administration) FDA 510(k) process work. The chart shown illustrates the (Food and Drug Administration) FDA approval process in USA.

Step 1 US FDA Medical Device Approval Process

Using the (Food and Drug Administration) FDA classification database, determine the classification of your device by researching Predicate Medical Devices already registered in the US market. Pay special attention to the three letters Device/ Equipment Code and 7 digits Regulation Number associated with the predicate Medical Equipment you identify. If no predicate found, use 513(g) / De Novo process. US FDA Medical Devices classification is made up of Class I, Class II and Class III.

Step 2 US FDA Medical Device Approval Process

Implement QMS which meets the (Food and Drug Administration) FDA Quality System Regulation found in 21 CFR Part 820. This is also commonly known as (Food and Drug Administration) FDA GMP.

Step 3 US FDA Medical Device Approval Process

Innovative Class II, and all Class III, Medical Devices will likely require clinical studies. Get Pre-Submission feedback from the (Food and Drug Administration) FDA.

Step 4 US FDA Medical Device Approval Process

If clinical studies will be required, apply for an Investigational Device Exemption. Develop clinical trial protocol and conduct studies.

Step 5 US FDA Medical Device Approval Process

For Class II Medical Devices, prepare & submit 510(k) Pre-market Notification application. Pay 510(k) / PMA submission fee. For Class III Medical Devices, prepare & submit Premarket Approval application. Pay PMA submission fee to (Food and Drug Administration) FDA.

Step 6 US FDA Medical Device Approval Process

For Class III Medical Devices, (Food and Drug Administration) FDA conducts facility inspections of all major Manufacturers /suppliers/ Exporters involved in the design & production of your Equipment. All parties must be compliant with (Food and Drug Administration) FDA QSR.

Step 7 US FDA Medical Device Approval Process

For Class II Medical Devices, the FDA (Food and Drug Administration) issues 510(k) clearance letter & posts it online. For Class III Medical Devices, the FDA (Food and Drug Administration) FDA issues PMA approval letter & posts it online.

Step 8 US FDA Medical Device Approval Process

At this time, you must be in full compliance with QSRs. The (Food and Drug Administration) FDA will not inspect Class I or II Medical device Manufacturers /suppliers/ Exporters for compliance prior to device registration but does conduct random inspections and can issue a Form 483 for non-compliance..

Step 9 US FDA Medical Device Approval Process

If you have no local presence in the US, appoint an (Food and Drug Administration) FDA US Agent representative as a local point of contact with the (Food and Drug Administration) FDA..

Step 10 US FDA Medical Device Approval Process

List your Medical Devices & register your company using FURLS system on the (Food and Drug Administration) FDA website in accordance with 21 CFR Part 807 contract /suppliers/ Exporters & sterilizers must also register & list. Specify your appointed US Agent. Your (Food and Drug Administration) FDA Establishment Registration and Listing must be renewed on a yearly basis.

Step 11 US FDA Medical Device Approval Process

You are now able to sell your device in the US. The FDA (Food and Drug Administration) listing on their website will serve as your authorization to commercialize your device in the US. This authorization does not expire as long as certain types of changes are not made, e.g., design, intended use.

Please give us the following information to quote you:

1. Name of product
2. Product photograph
3. Intended use of the product
4. Technical specification of the product.

If Your Buyers Demanding for US FDA Certification Registration Services - Contact Now!
Mr. Puneet Sharma | Call: 08196980555 | Email: Meddevices.net@Gmail.com

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