Your Guide to the FDA Medical Device Approval Process

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Blog by Trinity M Consulting LLC

The FDA medical device approval process has changed several times over the years. We take a look at how these processes work now.

In 2020, there were 40 medical devices passed by the premarket approval process outlined by the U.S. Food and Drug Administration (FDA). Premarket approval is the most difficult approval process by the FDA for Class III medical devices.

While 40 medical devices might not seem like a lot, it is almost 25% more than over 30 years ago. The FDA medical device approval process has changed over the course of the past few years and decades.

This had led to new criteria and guidelines that are important for manufacturing practices to constantly be aware of. If you have an interest in learning more about the changes and modernization of the approval process, then keep reading on.

What Is a Medical Device?

A medical device undergoes different regulations and approvals compared to drugs or drug trials. A medical device's use for humans can help diagnose, cure, or treat various diseases and illnesses.

According to the FDA, a medical device can be any of the following things:

  • Instrument
  • Apparatus
  • Machine
  • Implant
  • Contrivance

If a company's equipment qualifies as a medical device, then it will have to uphold certain performance standards in the United States. This means it will be under strict regulation and monitoring by the laws or regulations outlined by the FDA.

FDA Medical Device Approval Process

All devices undergo registration and listing so that the FDA can monitor the device's uses. The premarket approval process and application have changed throughout time. Currently, there are steps around it that are addressed later on.

Each device requires verification before implementation in a clinic or public setting. Once a medical device arrives in the United States, there are a few steps that are taken.

First, the FDA employees will assess who the manufacturer and importer are. Then they will review the product description and Affirmations of Compliance. If all of the information that is pulled on the medical device is accurate, then it undergoes registration and listing.

Additionally, the FDA will regularly perform field examinations. These examinations gather samples from each medical device. After the samples are gathered, they will undergo testing for adherence to guidelines and standards.

Navigating the realm of FDA approval processes is difficult and time-consuming. There are many regulations, forms, and manufacturers that are involved. Medical device consultants are helpful in navigating the waters of the approval process.

They can also clarify any testing or procedures that need to be in place prior to FDA submission.

Medical Device Classification

The three different standards of medical devices are important for how the FDA approves its uses. The FDA lists all medical devices under Class I, Class II, or Class III codes.

The classification that a medical device falls under indicates its risk, safety, or effectiveness. For example, Class I presents with fairly low risk while Class III is a much higher risk.

For that reason, Class III medical devices also require premarket approval. There have been some changes made to the classification of devices since 1976. Any device before that time frame falls under the pretense of a "preamendment device."

As of the amendment in 2013, the FDA can reclassify it under the Class I-III categories if it has enough reason and justification for the change. It can also require premarket approval if it is not reclassified.

Since 1976, all medical devices are categorized as Class III and require submission of premarket approval. There are some exceptions to this. For instance, if the device is relatively low risk, companies can opt for the de novo process to be enacted.

Devices can also be reclassified under Class I or II later on.

Changes Throughout Time

The classification adjustment for devices pre-1976 versus post was one of the larger medical device law changes. To better understand the FDA approval process now, it helps to take a look back in history.

The FDA gained roots in 1906 with the Pure Food and Drugs Act. By 1968, it was already creating standardization for equipment such as X-Rays and MRIs.

In 1976, legislation passed new laws and regulations. These new enactments included the Premarket Approval process and the 510(k) premarket notification.

These new changes affected manufacturing practices and created stricter rules that monitored how medical devices affected humans. It also gave the FDA permission to ban devices that were unsafe.

A year later, the De Novo program was established. This gave device manufacturers easier routes for classifying their products as Class I or Class II devices.

As you can imagine, the medical device approval process can be costly and lengthy. In the early 2000s, the FDA created the Small Business Determination program. This allowed small businesses to apply for premarket approval at a reduced cost.

A larger change was brought about to the 510(k) premarket approval by 2012. This change affected those going through the De Novo program with Class I or Class II medical devices. It allowed them to skip the submission of a 510(k) application.

During the past five years, more changes have come about to update the approval process and regulate medical devices. These changes have centralized the Institutional Review Board and dived further into regulating medical software.

Recent 510(k) Changes

Within the past few years, the 510(k) approval process has undergone some changes. This largely came about as manufacturers were complaining about the basis of performance standards.

Since 1976, many devices are being compared to their counterparts that are decades old. Now, the FDA is making it so that new products maintain standards set within the past ten years.

The new 510(k) pathway looks to modernize the criteria and standards for upcoming medical device submissions.

Modern Era

The FDA medical device approval process has worked towards easier approaches. However, it is still difficult to understand and work through when you are trying to get a medical device approved. Through the new changes in the 510(k) approval process, devices are regulated more strictly against newer technology and standards.

If you are looking for help with product development, medical writing, or project management, then contact us today. You can let one of our skilled consultants help you with any of your project or company needs.



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