Medical Device Regulation & How It Works

There are many questions circulating recently about how the process for medical device regulation works. Responsible regulation is a must when it comes to medical devices because they are often used in such life-altering ways. If companies producing these devices aren’t held to a high standard, then it could be very harmful to the patients who are relying on these devices for their survival. While it is a very complicated subject, I decided to break it down in a way that is easier to understand to ease peoples concerns about the development of such devices.
Medical devices are regulated by the U.S. Food And Drug Administration, more often referred to as the FDA. The overall purpose and mission of the FDA is to protect public health, but more specifically, they monitor and ensure the safety of drugs, biological products, and medical devices. They are also in charge of regulating tobacco products, food supply, and cosmetics. Needless to say, they are the people in charge.
In terms of medical devices specifically, they are the ones who are in control of making sure the firms who are manufacturing, repackaging, relabeling medical devices are doing so in a responsible way that adheres to FDA regulations. There are three different classes of medical devices, Class I, II, and III. They are classified this way because the different levels require different regulatory requirements. The basic overview of said requirements is as follows:
- Establishment Registration
- Medical Device Listing
- Premarket Notification
- Premarket Approval
- Investigational Device Exemption
- Quality Regulation
- Labeling Requirements
- Medical Device Reporting
If you are someone who is involved in the development of a medical device, your first step is to find out if the product is regulated by the FDA’s Center for Devices and Radiological Health. From there, you will be able to determine what steps it takes in order to receive FDA approval on your device, beginning by defining the class of your medical device.
While the world of medical devices may seem mysterious, it is very clear that it is something that is well regulated by the United States government. Medical devices are responsible for saving thousands of lives with the developments that have been made over the years, and will only continue to do so in the future.
Originally posted on MarcelPena.com.
