How is a medical device certified by the FDA?

In this blog we have discussed how to obtain a CE marking for your medical device in Europe. But what is the system like in the United States? This must be done through the Food and Drug Administration (FDA). This is the consumer protection agency of the Federal Government of the United States. The FDA regulates medical devices and radiation-emitting devices, the latter two of which are regulated by the Center for Devices and Radiological Health, or CDRH.

The CDRH evaluates the safety and effectiveness of medical devices before they enter the market. It also ensures that they remain safe once they reach the market.

What is a medical device for the FDA?

For the FDA, a medical device is an instrument, apparatus, machine, implant, or in vitro reagent, including components, parts, or accessories, that diagnoses, cures, treats, or prevents a disease or condition. This is achieved by acting on the structure or function of the body in a way that does not involve chemical intervention or the use of drugs or medicines.

This definition excludes software dedicated to the storage and support of administrative data, and the transmission of electronic patient records.

How are they classified?

The classification is based on the description of the device (physical characteristics and intended use). The FDA classifies devices as Class I, II, or III. The class of a device increases with the level of risk and is assigned a three-letter code, called a Product Code. This allows the FDA to group devices with similar intended uses.

As the risk of devices increases, so does regulatory scrutiny to ensure their safety and effectiveness. Controls can be general, special (through the pre-market notification procedure, called 510(k)), and pre-market approval (PMA). Some devices may be exempt from FDA filing or requiring 510(k) or PMA. For example, Class I devices only have to pass general checks and most are exempt from submitting pre-market applications, but some may be required to submit a 510(k).

How to introduce your new medical device to the US market?

There are 5 steps.

  1. Describe in detail your product, both the design of the product and its purpose. The purpose can be described in terms of intended use as well as indications of use. You should describe the duration of use of your product, as well as the type of patient you are targeting, such as use for a certain age range, or disease condition.
  2. Confirm that the product is a medical device. This goes back to the FDA’s legal definition of a medical device.
  3. Classify the product to see if it is Class I, II, or III, and will generally inform you whether a regulatory filing will be required for the device to enter the market.
  4. Generate the necessary information to ensure its safety and effectiveness. This is valid scientific evidence to support your device. This may include preclinical, animal, and clinical trials.
  5. Prepare and submit a pre-market application for your product to enter the market. There are 5 types of pre-market applications, each with its own set of processes, applicable requirements, review time, and body of evidence.

Types of pre-market application

There are 5 types: Investigational device exemption, pre-market notification (510(k)), pre-market approval application (PMA), De Novo, or humanitarian device exemption.

510(k) is a marketing application for low-risk or moderate-risk devices – such as Class I or II devices. The 510(k) is a comparative type of application. For the FDA, a new medical device is substantially equivalent to a predicate device, which is legally marketed as a Class I or II device. FDA examines three main aspects: the intended use, the characteristics or risks of a device, and, if necessary, the results of performance testing.

The PMA is a market application for high-risk devices – such as Class III devices, as well as devices without an existing classification. In a PMA, it must be demonstrated that the safety and effectiveness of the device can be reasonably assured. Unlike a 510(k), evidence of a PMA must stand on its own. There is no legally marketed equivalent.

At EpisKey Medical Consulting we have specialists who are perfectly familiar with the procedures for obtaining a registration that will help you to market your product in the United States.

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