Talking about FDA certification? Among them, according to the medical use and possible harm to the human body, the FDA will be divided into medical devices Ⅰ, Ⅱ, Ⅲ, the higher the category the more supervision.
Some media outlets have introduced in their articles that only products with the highest risk level above Class III that are not exempted from the 510K, and applying for FDA registration, are called "FDA Approved" (FDAApproved). And the TriPollar Stop line of products, i.e., radiofrequency cosmetic devices should belong to Class II medical devices, and what they get should be ? Marketing Authorization (FDA Cleared)? instead of FDA Cleared. Certification. and therefore have False advertising
Nanjing Jaguar explained that if a brand new technology, the FDA has not previously endorsed and approved the technology, and the pre-market clinical trial proved that it is safe and effective, it will be approved by the FDA, and if other products use the same technology, the product will pass the FDA Cleared after proving to the FDA that the ingredients, technology, parameters and other elements of the product are equally safe and effective as the products that have already been approved by the FDA.
Therefore, NJ Puma believes that the radio frequency technology used in the TriPollar Stop products has already been FDA Approved in previous products, and therefore in the description of this series of products, it is referred to as "FDA Cleared". Therefore, in the description of this product line, it is referred to as "FDA Cleared". FDA Cleared? There is no problem. The company believes that the ambiguity in the description is a matter of academic debate and translation, not an intentional misrepresentation of facts.
In recent years, the demand for beauty meters in China is blowing up. Due to the characteristics of the products, the businessmen attach great importance to various test reports, qualifications and certifications, and other data can be imagined. A variety of dazzling advertising campaigns, it is inevitable that controversial voices will appear.
In fact, for the market?FDA certification? s claims, previously there have been professionals have been concerned. In October this year, Dongwei Chengdu law firm issued an article to explain this.
The law firm introduced in the article, now on the market for home beauty equipment advertised its FDA certification, most of which refers to the 510K pathway to obtain marketing authorization to become a Class II medical device. The 510(k) pathway to FDA Class II medical device certification for a home beauty device simply means that the device is consistent in terms of safety and efficacy compared to existing devices, constituting substantial equivalence, and thus is permitted to be marketed in the U.S. market in the capacity and for the purposes of a medical device.
That is to say, the 510(k) pathway through the FDA's marketing authorization (FDA Cleared), in the publicity can only indicate that ? The device is consistent in terms of safety and efficacy compared to existing devices? and? Cleared for sale in the U.S.? Therefore, if the publicity of the product on the FDA certification goes beyond the above explanation, and the publicity terms are not consistent with the records in the documents submitted to the FDA, it is suspected of false publicity," said Dongwei Chengdu Law Firm. Dongwei Chengdu law firm said.
So, TriPollar-related products on the Tmall platform to? Its products have 13 technical certifications from the authoritative organization FDA? as a publicity slogan, whether there are suspicions beyond the scope of the above explanation?
In this regard, China Economic Weekly called Nanjing Jaguar on the afternoon of December 28 and sent an interview letter. As of press time, did not get a response from the other side.
If Nanjing Puma on the ?FDA certification? is officially recognized as exaggerated propaganda, what measures can consumers take?
China's "Law on the Protection of Consumers' Rights and Interests," Article 8 states? Consumers have the right to know the real situation of the goods they buy, use or services they receive; Article 55, paragraph 1 provides? Operators to provide goods or services with fraudulent behavior, should be in accordance with the requirements of the consumer to increase the compensation for the losses suffered by the consumer, the amount of increased compensation for the consumer to purchase goods or services received three times the cost of the goods; increase the amount of compensation is less than five hundred yuan, for five hundred yuan. If the law provides otherwise, in accordance with its provisions.
According to the above provisions, if ? Exaggerated publicity? is established, the consumer to TriPollar StopVx in Tmall on December 30 price 4482 yuan, the merchant in addition to should refund consumers 4482 yuan, but also should be additional compensation for consumers 13446 yuan.