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How to get new medical device approved?

medical device compliance
medical device compliance

If you are trying to market a medical device, the Food and Drug Administration, or FDA, must clear your product for medical compliance. There is a rigorous process and there are fees involved as well. Medical devices can fall under three separate classes that are relevant to the FDA compliance approval process, and, in the following, they are explained in much greater detail. Getting a medical device approved can be done a couple of different ways.


After you put together your creation, you must determine what classification it is. The three classes are simply known as class I, II, and III. What property earns the devices this classification is usually the risk it offers users. The lowest level, class I, is associated with devices that are not harmful to consumers in any way. Tongue depressors and thermometers are both types of class I devices. These have a relatively easy procedure to follow to get approved by the FDA.

Class II and Class III Devices

Class II devices include blood pressure kits, electric wheelchairs, infusion pumps, and bone screws. These have more steps involved when it comes to device compliance approval by the FDA. Class III products are usually associated with products that may be harmful if not used correctly and require a much more strict process for compliance approval. This class of devices can often be life-sustaining devices or have other important uses. Pacemakers, leaders, HIV diagnostic tests, and artificial knee joints fall into this category.

Class Specific Requirements

The FDA offers a pre-marketing submission process that is required. Information about the general controls get assigned and recorded for the device. Finally, when dealing with the third class, general controls and Pre-market approval are of what is important for getting your product approved.

Pre-marketing Submission

Find out if you can through the fast track 501K so you can market your medical device. Luckily, if you have a device that falls under either class I or class II without any exemptions, you will be asked to present a Pre-market notification of 501K when it comes to marketing. But, by chance, if your device also underclass. You must present a Pre-market approval, for PMA, unless it is a pre-amendments device. If that happens to be the case, you will then be required to present a 501k.

When it comes to getting your device approved by the medical regulations the FDA has set up, you must make sure that your product has already been classified. There are, however, many biological products and drugs that are not considered medical devices. These must be taken care of even with even more detail.

What to Expect

It can typically take between four and twenty years, as well as cost a company up to 300 million dollars depending on how complex the device is and what regulatory path it takes for FDA clearance or approval. There are many medical devices that are not classified as life-sustaining that can be brought to the market more quickly through other means, but the original process will remain time-consuming and expensive.

Main Concerns

What the FDA is mainly concerned with is determining whether a new medical device actually does what it claims to do in a safe and effective manner. If you have a device that falls under either class I or class II without exemptions, you will be asked to present your information and make it out with minimal harm. The whole pre-marketing approval process can include several lengthy stages of preclinical treatment preclinical trials and formal FDA reviews prior to the final market decision.

There are plenty of criticisms to the FDA device approval process. The manufacturers of devices states that the process is far too complex, and slows the introduction of new and innovative devices onto the US market. The FDA retaliates stating that the approval of medical devices, with the aim of bringing new important technologies that are safe and effective more quickly to US patient, while trying to balance the benefits and risks of new technology. Many critics of the FDA’s 501K feel it is necessary to speed these new technologies to clients.

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