How Does the FDA Clear Medical Devices?

In the United States of America, the FDA regulates all companies that design, manufacture and import medical devices. The FDA’s Centre for Devices and Radiological Health (CDRH) is responsible for enforcing medical device regulations and ensuring the health and safety of the public.


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When a medical device is set for market, the FDA must clear or approve it. Clearing is done after a premarket notification, or 510k has been filed, and approval is granted when a premarket approval application is reviewed. Clearing or approval will depend on the type of device intended for market.

Correct Terminology

A large number of medical products bear the words FDA approved, cleared or registered, but these terms may be somewhat misleading. In reality, the FDA may only approve drugs or medical products that are life sustaining, and are classified as Class 3. A defibrillator is one such example, and Class 3 products are all submitted to stringent PMA testing processes before they are allowed on the market. These processes must prove the product benefits the patient and outweighs any potential risk.

Low risk medical devices such as gauze, stethoscopes or thermometers are classed as Class 1, whilst Class 2 devices include everything from X ray machines to physiotherapy equipment. Class 1 and 2 devices do not have to be FDA approved, but they do require clearance before they can be sold. This is where the difference between FDA cleared or listed comes in, as only drugs and Class 3 devices are actually FDA approved.

Going to Market

Obtaining clearance or FDA approval is essential for anyone wanting to release a medical product to the market, and for this reason there’s a demand for companies to help with FDA 510k clearance. A company such as can speed up the process in getting a product to market, and thus maximise profit potential. It can take up to 12 years for a product or drug to go from concept to market, so a service that can assist in securing the necessary 510k clearance is incredibly valuable.

To acquire clearance to release a medical device there must be proof that the device is sustainably equivalent to another device that is already legally marketed for the same purposes, and the applicant must prove that the device is safe and effective.

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