Why the FDA approves gadgets worth the money

Why the FDA approves gadgets worth the money

When you buy various gadgets, such as fitness trackers, smartwatches, and heart rate monitors, you will see the mark “FDA approved.” However, users do not always fully understand what this designation means. Some treat it as a guarantee of quality and efficiency, and some think it is just a marketing ploy.

When you buy various gadgets, such as fitness trackers, smartwatches, and heart rate monitors, you will see the mark “FDA approved.”

However, users do not always fully understand what this designation means. Some treat it as a guarantee of quality and efficiency, and some think it is just a marketing ploy. In this article, the specialists from companies that developed the electronic tool for clinical research, OnlineCRF, briefly explain what the FDA-approved wording for the buyer and user of the gadgets means.

What does the FDA do?

The Food and Drug Administration (FDA) is an organization that is involved in the control and sanitary supervision of the quality of food, medicine, and medical devices.

Medical devices include those that can be used for diagnosis and treatment. These include devices for measuring heart rate, pressure, etc. However, there is an important clarification. Not all of these devices can be called medical devices. An important difference between a medical device and a gadget (or Wearable tech) is FDA approval and verification. If the device has passed the test and received the “FDA approved” mark, this means that it can be used for diagnostic and therapeutic purposes, for example, confirming a diagnosis or monitoring the success of treatment. Otherwise, the readings of the device are for informational purposes only and do not claim to be accurate and reliable.

Be attentive to manufacturers’ statements

In some cases, manufacturers of gadgets, such as smartwatches or fitness bracelets, may argue that their device can be used for medical purposes: to monitor health indicators, etc.

These statements can be formulated legally correct, but at the same time, they will not meet user expectations. Understanding the situation will help mark “FDA approved”. If it is, the manufacturer’s statements about the accuracy and reliability of the measurements are true, and the device can be used in diagnosis and treatment. If there is no mark, the readings of the device do not hold medical weight, and you cannot guarantee that the device is working and measures the indicators correctly.

How the FDA confirms the quality of devices

Let’s see why FDA approval can guarantee the safety and reliability of the device, which this organization specifically checks.

For the FDA to approve the device, the manufacturer must conduct a series of clinical studies. In the course of their device, doctors will repeatedly check the device: compare it with standard devices, evaluate reliability and performance under different conditions. Doctors collect all the data into the Electronic Data Capture (EDC) system for further analysis by a specialist with medical statistics. The manufacturer submits the results of this research to the FDA.

And if the organization finds the data reliable and convincing, the device receives the mark “FDA approved”.

At the same time, device manufacturers who do not register their devices with the FDA are not required to verify them in this way.

Note! The FDA may not approve the entire device, but only one of the pieces of technology in it

Another important point for the user: If the device is marked “FDA approved”, this does not always mean that the organization checked all the parameters of the device. Some devices may have separate measurement technologies or sensors that have been tested by the FDA.

For example, a smartwatch can measure heart rate, pressure, and the number of steps taken. These are three different sensors, and one of them may be FDA approved, but the rest not. So, if the device uses an approved technology for measuring heart rate, then only the heart rate can be clinically significant, and all other information from the device cannot be used in diagnostics.

We recommend that you check this point before buying and checking whether the entire device is approved or only an individual piece of technology in it.

Approved gadgets can be more expensive

Clinical trials and the entire FDA approval process are quite laborious and expensive for the manufacturer. This may affect the final price of the device. However, the user must understand what he or she is overpaying for.

If you plan to buy a gadget that bears the FDA approval tag, this means:

• Devices checked by an independent regulatory body and all its declared parameters are true. For example, if a clinically accurate measurement of the pulse is declared, it will be so. All data collected by Electronic Data Capture (EDC) system for clinical trials for further analysis.
• The parameters of this device have been tested in clinical trials. It has been proven that the functions of the device really work correctly.
• Parameters, technological schemes, and device mechanics are checked and documented. That is, as long as the device has the FDA mark, the manufacturer will not change its parameter and design. Otherwise, they must remove this mark or approve the device again.

If you see the “FDA approved” mark on the device, be aware that this is not just a marketing ploy. This means that the device is truly safe, and the information it collects is clinically significant. You can count on the device to determine the correct measurements that can be used for diagnostic and therapeutic purposes.

And if your fitness tracker does not have such a mark, then the steps, calories, and other parameters are for informational purposes only and cannot be used for diagnosis or treatment.