When examining advertisements for medical devices, it is common to come across the phrase "FDA approved" to enhance the credibility and awareness of their products. However, upon closer inspection, it becomes apparent that some products do not require FDA approval, yet the term "approved" is often misused, leading to confusion. This can potentially be considered false or misleading advertising, so medical device companies need to exercise caution when using such terminology.
The FDA classifies medical devices into three categories (Class I, II, and III) based on their level of risk, with higher classes indicating higher risks and stricter regulatory controls.
- FDA Registered
For Class I devices, a registration process is only required. This is for FDA establishment registration and device listing, which simply notifies that the company's devices are being sold in the United States. It does not involve the process of demonstrating the safety or efficacy of the devices. For these devices, neither the terms "FDA cleared" nor "FDA approved" can be used.
- FDA Cleared
For Class II devices, a pre-market notification process known as 510(k) is necessary, where equivalence to a previously 510(k)-cleared device needs to be demonstrated. Hence, it is crucial to emphasize that in these situations, the use of the term "FDA approved" is not appropriate.
- FDA Approved
For Class III devices, which pose the highest level of risk, pre-market approval (PMA) is required before they can be marketed. This process involves providing scientific evidence to demonstrate the safety and effectiveness of the device for its intended use. Therefore, only products that have undergone pre-market approval can be considered FDA-approved.
It is important to note that in any of the cases, you cannot use the advertising phrase "FDA registered", “FDA cleared” or "FDA approved" on the product label.
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