FDA Medical Device Approval in the United States

In the United States (US), the role of the Food and Drug Administration (FDA) is to protect public health by allowing only safe and effective products to enter the market, and by monitoring products for continued safety after they are in use. The FDA is responsible for regulating companies that manufacture or import Medical Devices sold in the US.

Medical device Strategy US FDA

Medical devices are classified into three classes by the FDA: Class I being the lowest risk and Class III the highest risk. (details on classification 21 CFR, parts 800-1107).

The low-risk medical devices, are known as "Class 1" and are exempt from FDA review. Medium risk devices require 510(k) Pre- market Notification to be sold in the US, while high-risk devices must go through the Premarket Approval (PMA) application under section 515 of the FD&C Act in order to obtain market access.

Medical Device Classification US FDA

The US FDA uses a predicate-based system to classify medical devices as Class I, II or III based on increased risk to the patient or user.

To find the classification of your device, as well as whether any exemptions may exist, you need to find the regulation number that is the classification regulation for your device. There are 2 methods to find this:
1. The classification database and search for a part of the device name
2. Device panel to which your device belongs.

For each of the devices classified by the FDA, the CFR gives a general description including the intended use, the class to which the device belongs and information about the marketing requirements. Your device should meet the definition in a classification regulation contained in 21 CFR – 862-892.

After the device classification, you then select the premarket submission required for that regulation

all routes to Market Access in the US


US FDA Agent

All medical devices have to be listed with the FDA (Medical Device Listing) and all companies intending to market their medical devices in the US must notify the FDA of their intention and be registered (Establishment Registration), prior to the introduction of their products into the US market. Regardless of the product classification, Quality Systems Regulations (QSR) compliance is almost always required. Companies that do not have a US mailing address also must designate a US FDA Agent to serve as their intermediary with the US FDA. 

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Our US services


Regulatory Affairs

Regulations vary depending on the medical device and market you wish to enter. Our teams offer support for all regulatory compliance issues worldwide.


Clinical Affairs

Experience a practical approach based on your existing regulatory data. Our team supports medical writing of clinical evaluations (MEDDEV 2.7.1.), as well as full-service CRO activities.



Quality Assurance

Implement and maintain a Quality Management System (QMS) to ensure your medical device meets certain specifications and requirements. 



In-house knowledge of regulatory and quality requirements facilitates the product-to-market process and provides insight into clinical safety and performance.




Audits are executed to determine regulatory compliance and improve the affectivity of your internal processes and those of your subcontractors and suppliers. 




Global Registration

Health authorities determine market approval based on different dossier formats and requirements. With our global network Qserve covers a large percentage of these markets around the world.

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