CE Mark Versus FDA Approval And What It Means For Dermal Fillers
One of the things we often see across social media within the aesthetics industry is some confusion around whether a product is FDA or CE approved or not and how these two certifications compare. With that in mind we put together this blog to help you tell the difference between the two certifications and what this means for the aesthetic industry as a whole.
Firstly it’s important to understand the jurisdictional difference between these two bodies.
The FDA is only responsible for regulating medicines and medical devices in the US & Mexico whereas the CE mark covers Europe and a number of other sovereign nations. The CE mark is also used as a benchmark by non-EU countries such as the situation in the UK, wherein the absence of the full roll-out of the UKCA mark most insurance companies are still advising the use of CE medical devices.
These two systems perform fundamentally the same functions, assessing the safety and the ability to achieve the desired effect of new medical devices. FDA approval is however a substantially more time-consuming process and expensive certification to obtain due to the protracted and somewhat outdated assessment process.
In order to get full FDA approval, clinical trials must be conducted with the FDA having to approve each trial before a device can move onto the next step in the assessment process. At the end of this process, a medical device awarded FDA approval will have clinically proven that it is safe and effective. This process is expensive some would say prohibitively so forcing smaller manufacturers that perhaps don’t have the millions in the capital it needs to complete the process from attempting to enter the US market with new innovations. It’s also time-consuming and can often mean life-altering treatments take several years to enter the US market.
In the EU, by contrast, the CE Mark applies more to whether the use of a surgical device is safe for the surgeon, the surgical staff, and the patient. The CE Mark does not determine the safety and the ability to achieve the desired effect of every surgical procedure that is performed by the device; these factors are rather left to the responsibility of the physicians and surgeons who use the device. This is a massive difference in regulating styles. The CE mark can be obtained through clinical evaluation, peer review of published data and review of equivalent devices. As part of the CE mark process, a post-market clinical study must be conducted in order to provide an ongoing safety assessment but these studies are significantly cheaper and easy to implement when compared to the FDA style clinical trials.
There are some advantages to the FDA’s assessment protocols, extended and multi-year assessments can highlight unseen complications that are only detectable through clinical trial evaluation.
How does this affect dermal fillers?
As it stands there are only seven FDA approved fillers with the market being dominated by Juvederm, Restylane and Boletero. Does this mean these fillers are technically any better than CE approved fillers, the answer is no. Does this mean these fillers are safer than CE approved fillers, again the answer is no.
What we can say is that the FDA approved fillers have undergone an extensive clinical trial over a significant amount of time to show that they are safe, but not necessarily safer than the CE fillers.
What it does mean is that the US is yet to see the benefit of dramatic improvements in crosslinking technology and other improvements within the hyaluronic acid dermal filler market because of its prohibitive testing methods. The cost and time involved in getting more modern, and more advanced fillers into the US acts as a barrier preventing new products entering the market. It’s not hard to see why the brands in the US are owned by pharmaceutical giants such as Allergan.
What the CE mark allows is for medical devices to be extensively tested for safety quickly (normally 8 months to 18 months) and introduced into the market cheaper than in the US allowing multiple safe fillers to enter the market. What is also done with ongoing spot testing is to allow fillers that no longer meet their initial testing standards to be removed from the market quickly.
The CE mark allows for innovation and product development which is great for the industry whereas the FDA does not.
Some people say FDA products are safer than European tested fillers as the testing procedure is longer, not everyone agrees with this statement. There is no more product recalls in Europe than in the United States, and there are stringent quality management systems that continue to monitor results after the CE Mark has been granted. Companies are audited regularly to ensure compliance.
In conclusion both FDA approved and CE approved fillers are safe, although FDA fillers will have clinically proven long term safety reports some CE fillers will not have due to the way CE testing works.
The CE system allows for more advanced and newer products to enter the market quickly once deemed safe.
The FDA focuses heavily on pre-market testing whereas the CE mark system focuses more on post-market surveillance and quality control.
Both systems achieve the same end result through different means, while only the CE mark creates a regulatory pathway that encourages product innovation.