US FDA Clearance vs US FDA Approval for Medical Devices

| |

It’s natural for us to think that everything FDA-cleared or authorised has undergone extensive testing, but that isn’t necessarily true. It is essential to be aware of the differences between US FDA Clearance vs US FDA Approval for Medical Devices. In this article, you will get to know about the US FDA Clearance vs US FDA Approval for Medical Devices.

What is the US FDA?

The Food and Drug Administration (FDA) is a division of the Department of Health and Human Services in the U.S.A. The FDA has been protecting consumers for more than 100 years. Thus, when it comes to expanding your business in the United States, US FDA Certification in India serves as both a strategic resource and a necessary accomplishment.

What is US FDA Certification?

Most Products such as food, drugs, cosmetics and colour additives must be FDA certified before they may be exported to the United States. This includes medical devices and supplements as well as personal protective equipment (PPE).

Protecting and managing public health in the USA is the primary goal of the US Food and Drug Administration (FDA). Hence, Certification from the US Food and Drug Administration is only a certificate to prove that your goods are safe and reliable.

cGMP (Current Goods Manufacturing Practices) is also a sign that the products being exported to the United States are in compliance with the FDA’s guidelines. Hence, people confuse receiving US FDA Certification with US FDA Clearance and US Approval.

US FDA Clearance vs US FDA Approval for Medical Devices

What is US FDA Clearance?

A medical device classified as a class II or class I by the FDA is considered to be “cleared,” meaning the seller or maker or manufacturer can show that their medical device is “closely identical to some other (similar) lawfully marketed item” which has already received FDA certification. In simple words, Companies can gain US FDA Clearance by demonstrating that their medical device is nearly identical to an existing FDA-cleared or approved medical device.

Which devices get US FDA Clearance?

  • The device is adapted from previous technologies and will serve the same function.
  • Technology-wise, the device is similar to an existing one but employs a new set of tools. However, the producer would need to offer more proof to support their product’s safety and efficacy claims.

Important Note: The FDA Clearance procedure for Class I and II medical devices is less rigorous than that for Class III medicinal products or devices since they represent a limited risk to the public.

What is the US FDA Approval?

Drugs, vaccinations, and Class III medical equipment must have US FDA approval before they can be marketed or sold in the United States, despite the fact that many of these goods can be beneficial to health.

In simple words, US FDA Approval is US FDA Certification that is mandatory for exporters worldwide to get their product shipped into US Markets and even several other nations. It is also known as Premarket Approval (PMA) and the US FDA provides certification for the approval.

Take a call from Expert

Importance of US FDA Certification in India

Furthermore, Medical devices can only be sold in the USA when they have been registered, cleared, or authorised by the Food and Drug Administration (FDA).

If you know How to Get US FDA Certificate in India you can also sell or market your products in India, Japan, China and several other nations.

ISO Certification for Medical Equipments

If you want any other guidance relating to the US FDA Certificationplease feel free to talk to our business advisors at 8881-069-069.

Download E-Startup Mobile App and Never miss the latest updates narrating to your business.


Is GST Registration required for Startups?

How to Start Yarn Business in India?


Leave a Comment