You should always know what products are used in your unique treatment plan and one of the things you might want to know, which I believe you should insist on knowing, is whether they have undergone clinical trials on humans.
There are several differences between the European and American standards, but for me this is the main one ... has this product been proved safe over time in humans? Human clinical trials obviously make a product more expensive to develop and therefore more expensive for the consumer ... but, in the case of Facial Aesthetics ... THIS IS ABOUT YOUR FACE!
CE MARK
• Main function is to assess the safety and efficacy of new devices
• Obtained through a clinical evaluation of published data for existing equivalent devices
• Requires a postmarket clinical follow-up study once the CE Mark is obtained
• Valid in all EU countries and recognized almost globally
• Puts more onus on and endues a greater amount of trust to the manufacturer and to the physician compared with the FDA approval system
• Allows new technology to more quickly become available to patients compared with the FDA approval system
• Leaves safety and efficacy of the surgical procedure that is performed by the device to the responsibility of the physicians and surgeons who use the device
FDA APPROVAL
• Main function is to assess the safety and efficacy of new devices
• Requires a full clinical trial or trials
• Narrow approved range of parameters
• Valid only in the United States
• More expensive to obtain compared with CE Mark, as the documentation required from investigators is much less efficient, the review cycle is about three times longer, and there are almost always more rounds of questions
• Indicates that strict criteria have been met, signifying that clinical application of a drug or device will be safe and effective
