When we require a medical device to help with our health, it’s not often that you think it will fail. After all, before this equipment can be used for patient care, it must be approved by the U.S. Food and Drug Administration (FDA). Medical devices go through extensive review by the FDA, during which the agency determines whether it’s safe for public use. There are multiple steps in the medical device approval process.

With all this scrutiny, you wouldn’t even think faulty products could make it to market, but our Kansas City product liability lawyers advise clients frequently about their rights after suffering injuries from defective medical products. 

The Medical Device Approval Process

As a consumer, you should understand the manufacturer’s duty and the FDA’s approval process. First and foremost, the manufacturer is responsible for producing a safe product. Secondly, the company has an obligation to follow the FDA guidelines. However, medical device product liability claims often happen because one or both of those duties wasn’t followed. Here’s what the FDA requires. 

Step One

This is classification for marketing. A manufacturer designates their classification based on the federal regulations under which their device falls. The manufacturer can help by identifying the classification, but the FDA gives the medical device an official classification during the review. The categories are:

  • 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 is 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 shows 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 follows the most stringent regulations regarding premarket submissions. The device must be proven safe and effective for its intended use before PMA can be approved by the FDA.
  • De Novo — Evaluation of Automatic Class III Designation. If a new medical device without a valid predicate meets certain criteria, it 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, a manufacturer gathers and prepares the necessary information required for that premarket submission. This often includes various types of information such as clinical evidence, nonclinical testing, design controls, and labeling. Preparing a premarket submission is a vital step, and certain premarket submission types require even more specific information the manufacturer should provide.

Step Four

A manufacturer pays the fees associated with the premarket submission type selected, makes an eCopy of the submission, and sends it to the FDA for review. The manufacturer can open discussions with the FDA during this phase of the process as the agency assesses whether the submission meets the requirements to be accepted for substantive review. Communication during the review process increases efficiency.

Step Five

Finally, a manufacturer registers 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 from the FDA. However, the registration of establishment and device doesn’t mean that the FDA has cleared or approved the establishment or device.

FDA Regulation of Medical Devices

The FDA is tasked with ongoing regulation of new medical devices as they go to market and beyond. Even devices approved as safe and effective by the FDA can later become defective. When this happens, patients who received these devices can sustain serious injuries. If various risks are linked to the use of the device, the FDA should take action. The agency either issues a public warning, places a black box warning on the device, or recalls it completely. This takes the device off the market and allows injured patients to seek compensation.

Manufacturers have a duty of care to ensure the safety of their products to prevent harm. This is an important part of the manufacturing process and should be taken seriously. If the manufacturer releases an unsafe medical device to market, it should be held accountable.

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