Non-invasive fat reduction methods have been gaining traction lately and while there are many reasons for that, the efficiency and safety of these procedures are on the top of the list.
They are often referred to as body sculpting procedures, which aptly describe what they do. These are outpatient procedures can be performed without anesthesia or recovery time. The reasons for the emergence of these procedures can be attributed to all of these factors.
While some may have noticed, some procedures have been noted as FDA Approved, and others, CE marked. But what does that mean for treatment and what does it entail when a treatment or device has been approved by the FDA?
In this article, we dive into what FDA approval or CE mark means for treatments and what it means for consumers in this article.
Should I be Looking Out For an FDA Approval?
It is important to check the safety and efficiency of such procedures before deciding to undergo any of them. FDA approval is the most accurate and reliable way to ensure that a procedure follows all health guidelines and is tested before being used on humans.
Just like someone would check if a medication is approved by FDA before consuming it, procedures and technologies approved by the FDA ensure maximal safety for consumer use.
What does FDA approval mean for a product?
Guidelines and protocols are developed by the FDA to ensure that medications or medical devices and biologics used by the general public are safe.
After FDA clears a product or drug, it can then be marketed to the general public. FDA approval is accepted worldwide, especially for pharmaceutical products and medical devices.
It is not enough for the FDA to simply approve or reject a device or drug. Multiple clinical trials must be analyzed thoroughly, and the device’s effectiveness in humans must be validated.
To be considered by the FDA, manufacturers must also submit premarket approvals.
How Does the Process take Place?
During this process, clinical trials are conducted by manufacturers and are strictly regulated by FDA guidelines. An FDA approval can be invalidated by the slightest error in the trials. This is how the FDA ensures that all guidelines are being met.
After thoroughly assessing all results, FDA may then approve the product. It means that the agency has evaluated the results and determined that the benefits outweigh the risks. This is known as FDA approval of a medication or a device. This is not the same as FDA clearance, which is common for medical devices.
As far as fat freezing treatments go, CoolSculpting is the only FDA-approved option for non-invasive fat reduction. Using technologies without this approval or clearance could mean that there are risks associated with the device.
It could also mean that the product isn’t in the final stages and hasn’t been submitted for FDA approval. There is a marked risk of complications with products used in any of these scenarios.
What does CE Mark mean?
Much like FDA approval in the US, there is a CE mark which is its equivalent in the European Economic Area (EEA). All devices, medical or other, manufactured in the EEA or outside of EEA, must have a CE mark before they can be sold freely in the EEA.
This mark means that the product meets all European safety guidelines and is safe for human use2. Unlike non-medical devices, which focus more on the voltage required for proper functioning, medical devices do not need to have a CE mark.
The manufacturer only needs to perform a clinical evaluation post-approval to obtain the CE mark, after the product has been launched on the market.
With the CE mark, manufacturers are trusted to verify that the testing they have done is sufficient to justify approval, and doctors have the same trust.
FDA Approval vs CE Mark: What’s the Difference?
FDA Approval and CE mark are both signs of safety and efficacy of medical devices in the US and Europe, respectively. CE mark has also become the standard for countries outside of the European Union such as Japan and Turkey.
FDA approval requires detailed clinical trials to be performed before they apply for FDA approval3. That in itself makes the process for FDA approval significantly longer than the process for obtaining the CE Mark. In fact, the FDA review cycle is generally up to three times longer than the CE mark review cycle.
FDA approval thoroughly assesses everything and makes the decision for everyone involved in the making and usage of the device4. The CE mark places trust in manufacturers and physicians.
Once a device has been submitted to the FDA for approval, clinicians and physicians cannot make changes to it5.
FDA approval is also much more expensive than the CE mark. The expenses of FDA approval arise from the extensive clinical trials that it requires. It is also more challenging to achieve FDA approval as the parameters accepted by the agency are all placed in a very narrow range.
Is FDA Approval really necessary?
FDA approval confirms that medical devices are safe and have met all required standards during manufacturing and shipping. It is crucial because it can only be obtained after the device meets very strict criteria, which cover all aspects of its functioning.
For FDA approval, it is critical that the device is tested at each step of the process. Every malfunction, no matter how minor, can be evaluated and the risks calculated.
That said, it is also necessary to receive FDA approval for non-invasive fat reduction medical devices7. Devices used in this process target the body with extreme temperatures to eliminate fat. Using the device regardless could result in a vast variety of side effects.
These approvals are a testament to the safety and efficacy of both devices and methods. By knowing the reasons behind the approvals, you can make more informed decisions when it comes to finding the ideal fat loss solution.
1. Gail A. Van Norman, Drugs, Devices, and the FDA: Part 2: An Overview of Approval Processes: FDA Approval of Medical Devices, JACC: Basic to Translational Science, Volume 1, Issue 4, 2016, Pages 277-287, ISSN 2452-302X, https://doi.org/10.1016/j.jacbts.2016.03.009. 2. Rosery, H., & Schönfelder, T. (2018). Healthcare System Stakeholders. In H. H. Bleß (Eds.) et. al., White Paper on Joint Replacement: Status of Hip and Knee Arthroplasty Care in Germany. (pp. 91–104). Springer.
3. P. Corr, D. Williams The pathway from idea to regulatory approval: examples for drug development B. Lo, M.J. Field (Eds.), Conflict of Interest in Medical Research, Education and Practice by the Institute of Medicine Committee on Conflict of Interest in Medical Research, Education and Practice, National Academy Press, Washington, DC (2009) 4. K.M. Fargen, D. Frei, D. Fiorella, et al. The FDA approval process for medical devices; an inherently flawed system, or valuable pathway for innovation?, J Neurointerv Surg, 5 (2013), pp. 269-275