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How Are Medical Devices Approved?

Jul 19, 2016

FDA approval stampWhen we require a medical device to help with our health, it’s not often that you think the device will fail. After all, before these medical devices can be offered to patients, they must be approved by the United States Food and Drug Administration (FDA). The medical devices must go through extensive review by the FDA, where the agency determines whether or not it is safe for public use. There are various steps the manufacturer of the device must take if they want market approval.

The FDA lists the steps that manufacturers should take, but before they do so, manufacturers should make the medical device is safe. If they fail to do so, significant injuries can result due to various defects with the product. As a consumer, you should understand the steps leading up to approval, as well as how the FDA goes about regulating medical devices. This can help you understand your rights if something happens as a result of a product defect.

Step One

The first step a manufacturer must go through is classification for marketing. The manufacturer will designate their own classification based on the federal regulations under which their device falls. The manufacturer can help by identifying the classification, but the FDA will give the medical device an official classification during the review. The categories include low risk Class I devices, such as toothbrushes; moderate risk Class II devices, such as non-invasive blood pressure monitors; high risk Class III devices, including heart valves and other medical devices.

Step Two

Once the medical device has been classified, the manufacturer chooses the correct required premarket submission regulation. These include the following:

  • 510(k) – Premarket Notification: This is usually required by some Class I and most Class II devices. The manufacturer would show that the new medical device is substantially equal to a predicate device in terms of performance testing, technological characteristics, and intended use.
  • PMA – Premarket Approval: This is required by most Class III devices and follow the most stringent regulations regarding premarket submissions. The device must be proven as safe and effective for its intended use before the PMA can be approved by the FDA.
  • De Novo – Evaluation of Automatic Class III Designation: If it meets a certain criteria, a new medical device without a valid predicate may be classified as a Class I or Class II by using the De Novo premarket submission.
  • HDE – Humanitarian Device Exemption: This premarket submission allows Class III devices to have a regulatory path when intended for use by patients with rare conditions and / or diseases. Before a medical device can qualify as an HDE, the Office of Orphan Products Development (OOPD) must approve designation as a Humanitarian Use Device.

Step Three

After selecting the premarket submission, the manufacturer would then gather and prepare the necessary information required for that premarket submission. This could include various information such as clinical evidence, nonclinical testing, design controls, and labeling. Preparing your premarket submission is important. Certain premarket submission types require specific information and the manufacturer should know.

Step Four

The manufacturer will then pay the fees associated with the premarket submission type they selected, make an eCopy of the submission, and send to the FDA for review. The manufacturer can open discussions with the FDA during the review process as they assess whether or not the submission meets the requirements to be accepted for substantive review. Communication during the review process can increase the efficiency.

Step Five

The manufacturer will register the establishment and its devices with the FDA. The manufacturer cannot add the device to the list — if it needs premarket approval or clearance — until it receives approval by the FDA. The registration of establishment and device does not mean that the FDA has cleared or approved the establishment or device.


The FDA is tasked with ongoing regulation of new medical devices as they go into market and beyond. Oftentimes, even devices that are approved as safe and effective by the FDA can later become defective. When this happens, the patients who have received these device can sustain serious injuries. If various risks are linked to use of the medical device, the FDA should take action. They can either provide a public warning, place a black box warning on the device, or recall it completely. This would take the device off the market and make it so the patients injured may seek compensation.

Manufacturers should be aware of the safety of their own products to prevent any dangers from reaching the consumer. This is an important part of the manufacturing process and should be taken seriously. If the manufacturer releases an unsafe medical device to market, they should be held accountable.

At Peterson & Associates, P.C.™, our team of Kansas City defective medical device lawyers is dedicated to providing our clients with the representation they need at such a difficult time. We know how complicated these types of cases are, especially when your focus should be on your own well-being and making sure you can recover as best as possible. We take the time to listen to your case, check the FDA review process on the defective medical device, and determine if you have a case. We can then advocate on your behalf and seek compensation for medical expenses, lost wages, and more.

Call us today to discuss your potential claim with a skilled attorney at our firm.

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Kansas City MO 64112

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