FDA, the U.S. Food and Drug Administration, is an international medical review authority, authorized by the federal government, specializing in food and drug regulation as the highest enforcement agency.
As a scientific regulatory agency, the FDA's responsibility is to ensure the safety of food, cosmetics, drugs, biological agents, medical devices and radiological products produced or imported into the United States, is one of the first federal agencies whose primary function is to protect consumers, while the FDA is recognized as one of the world's largest food and drug regulatory agencies, many other countries have sought and received help from the FDA to promote and Many other countries seek and receive help from the FDA to promote and monitor the safety of their own products.
Strictly speaking, there is no FDA certification, which the FDA itself has also said. Generally speaking, FDA certification refers to the following three main types: FDA registration, FDA testing and FDA approval.
① FDA registration: for exporting food, drugs, and medical devices to the United States of America, companies must register with the FDA for corporate listing and product listing, otherwise customs will not clear the customs, which is a mandatory requirement.
② FDA testing: FDA testing refers more to the safety testing of food contact materials, product contact class packaging testing, biocompatibility testing of medical products, clinical safety testing, etc.
③ FDA approval: This is generally more for drugs, that is, to allow the drug to be listed
1. FDA registration for laser products
Valid for one year, renewed every July
Laser products include: laser pointer, laser presentation, laser display, products containing laser units (DVD, CD-ROM, CD player, laser printer, etc.) safety protection and rescue products.
2. FDA testing of food contact materials
① food to do FDA does not need to pay the annual fee in U.S. dollars
② Renewed every even numbered years
③ There is no public inquiry method after the successful registration of FDA for food products, you need user name and password to log in the background before you can inquire
Food FDA registration steps:
Step 1: Confirm whether the product belongs to FDA food control scope
Step 2: Select a U.S. agent (US AGENT)
Step 3: Prepare English information of the enterprise and English information of the product
After the successful registration of food products, you will get the registration number of the enterprise, the cost is included in the registration and the payment of the U.S. agent service, the period is 3-5 working days
3. FDA test reports for cosmetics and daily products
There are two types of FDA cosmetic registration: factory registration and product registration
① Factory registration: first apply for the account, to be confirmed by the FDA and then submit the registration to be approved by the FDA, the cycle time is 2 weeks.
② Product registration: The premise of product registration requires factory registration first, followed by submission of product ingredients, the cost of ingredient registration multiplies with the ingredients.
Cosmetics registration will be successful in obtaining the business registration number and CPIS product composition filing number (cosmetics registration and food similar, need to check the background, can not directly query)
4. Medical device FDA registration
Including enterprise registration and product listing two parts.
After registration is completed, enter the corresponding registration code, query code, or the name of the company can be checked on the FDA to the relevant information.
Fees include two aspects:
One is the annual fee charged by the U.S. FDA, which is paid directly to the FDA in the form of U.S. dollars, and renewed every year from October 1 to December 31 for the next year to maintain the validity of the FDA registration, and the amount of the annual fee varies from year to year. (A class of medical devices annual fee is currently $5546, an average annual increase of hundreds of dollars)
The other is the agent fee charged (is included in the company registration, product registration, U.S. agent).
After successful registration there will be three numbers:
① Medical device facility registration number Registration or FEI Number
② Owner/Operator Number
③ Product Registration Number Listing Number
Companies choose to register FDA in October-December each year is the most cost-effective, after October 1 registration FDA, registration number can continue to use until the end of the next year, pay the annual fee for one year, registration number can be used for 3 months more.
The FDA registration cycle is 1-2 weeks (after the registered company successfully pays the annual fee to the FDA), the first will have the Owner/Operator Number and the product registration number ising Number, which can be directly cleared. Registered devices that have not yet received the "Medical Device Facility Registration Number" can temporarily use this number as the "Medical Device Facility Registration Number" for export customs clearance. Among them, the Registration or FEI Number needs to wait for the FDA to assign.
5. FDA registration for food, drugs, cosmetics and daily necessities
Step 1: Do the testing according to FDA standards and get the test report
Step 2: After getting the test report, we will act as your U.S. agent and go to the FDA database to check whether the corresponding standards meet the relevant requirements of the FDA. Then we will get the certificate of compliance from the FDA.
1. Product categorization: suitable for testing specifications recommended testing projects, suitable for registration specifications recommended to do the book.
2. Fill out the application form related to testing or registration
3. Need to do the test need to provide sufficient samples to the laboratory for testing
4. Both parties sign a quotation contract and arrange payment
5. Issuance of qualified report after passing the test, or registration certificate
Question 1: Which agency issues the FDA certificate?
A: There is no certificate for FDA registration, the product will be registered by FDA, the registration number will be obtained, FDA will give the applicant a reply letter (with the signature of the FDA administrator), but there is no FDA certificate.
Question 2: Does FDA need a designated certification laboratory to test?
A: FDA is a law enforcement agency, not a service agency, if someone says they are a certified laboratory under FDA, then he is at least misleading consumers, because FDA does not have a public service certification body and laboratory, and there is no so-called "designated laboratory". The FDA will only recognize the GMP quality of service testing laboratories and issue certificates of compliance if qualified, but will not "designate" or recommend a specific one or several to the public.
Teeth whitening devices are considered medical devices by the FDA. All medical devices are classified into one of three categories based on the type and degree of risk they pose to the user. The following is a breakdown of these classes:
Class III - These medical devices pose the highest consumer risk and must pass rigorous scientific testing before they can be designated as "FDA approved" and marketed to the public. Examples include mechanical heart valves and implantable infusion pumps
Class II - These devices pose a moderate risk to consumers. To receive "FDA approval," these devices must demonstrate "substantial equivalence" to other devices already on the market. Examples include dialysis machines and catheters.
Class I - These devices pose a low risk to the user and do not require premarket testing and evaluation beyond compliance with general safety controls. Tooth whitening devices and products, examination gloves, and breast pumps all fall into this category.
Tooth-whitening devices can only be registered with the FDA and are not approved
Because tooth whitening agents are Class I medical devices, the FDA has not granted approval for them. However, these devices must still be registered with the FDA to show that they comply with general safety and effectiveness regulations. Once a device meets the requirements, it can legally call itself "FDA registered" to assure consumers that it meets the requirements of this low-risk category.
It is important to note that the use of an FDA-licensed or approved designation on a device that does not merit such a claim may result in criminal prosecution by the federal government. In addition, the official FDA mark is not permitted on any private-sector products. If you see the logo on a teeth whitening product, you should be skeptical and investigate the credentials of
1. Evaluate the brand
Registration with the FDA is only part of the proof that a teeth whitening device is safe. Clinical trials provide evidence that the product delivers on its whitening efficacy. Recognition by prestigious organizations such as the Edison Awards also indicates standing in the professional community. Most importantly, make sure the company stands behind its products and will offer a refund if you are not satisfied with the product - not just more products.
2. Check the teeth whitener ingredients
Before you put it in your mouth, make sure the product you are considering contains safe at-home teeth whitening ingredients. Look for an active ingredient, such as hydrogen peroxide gel, that has been shown to safely and effectively break down stains without harmful side effects. Be wary of so-called "active" ingredients such as carbamide peroxide, which may not work and may even cause adverse reactions.
3. Consider Sensitivity
The most common complaint about teeth whitening products is tooth sensitivity. The best at-home teeth whitening products use desensitizers such as potassium nitrate and thick gel formulations to minimize sensitivity, and these formulations will not run down onto sensitive gums.
4. Look for recommendations from your dentist
Products invented by practicing dentists and used in dental offices across the country carry the weight of expertise and experience behind them. You may have seen advertisements for GLO Science products in your own dentist's office. Ask them if they think these teeth whitener kits are safe.
5. Consider how it fits into your lifestyle
Some teeth whitening devices are more convenient and faster-acting than others. If you do not have time to whiten your teeth at home, look for products that
Offer hands-free use, so you can perform multiple tasks while whitening
Are easy to use with Bluetooth connectivity and online resources
Achieve results in a manageable treatment time
6. Decide what results you want
Whether you're a first-time user who needs intense whitening or a regular whitener looking for a touch-up, the best teeth whitening products offer both options. Don't believe the dazzling dental claims of disposable products. Teeth whitening requires repetition and regular maintenance.
7. Weigh the price point
Low-priced products in drugstores are tempting, but they can lead to zero whitening results, an unpleasant experience, sensitivity, and an empty wallet. Investing in proven technology from a well-known brand usually results in the best teeth whitening results and a better overall experience, as well as a high-quality, long-lasting product that you can use every time you need to whiten.
8. Make sure you'll get support
Who do you contact if you have questions about safe at-home teeth whitening ingredients or how to keep your teeth white over time? The teeth whitening system that's best for you includes customer service support, and there are many ways you can contact for advice, guidance and information.
If you do not like the uncertainty associated with using over-the-counter teeth whitening products, you are better off seeing your dentist for professional teeth whitening.
All teeth whitening products used by dentists are subject to FDA approval. This includes not only peroxide gels, but also any activation methods used, such as special lights.
In addition to being safer, professional teeth whitening treatments are also more effective than over-the-counter products. Because they are performed under the care of an experienced dental professional, they contain stronger bleaching agents that can more dramatically improve the color of your teeth. In addition, the treatment is more comfortable because instead of using awkward strips and trays, the whitening agent is carefully applied to the teeth. In addition, the dentist protects the gums to prevent irritation - a common response from users of home whitening products.
FDA-approved teeth whitening gel
FDA-approved teeth whitening kit
All of the ingredients in onuge teeth whitening kit are FDA approved, making this product a safe way to whiten your teeth at home.
FDA-approved teeth whitening strip
The U.S. Food and Drug Administration (FDA) regulates the safety and efficacy of teeth whitening products. Teeth whitening strips are a popular over-the-counter (OTC) option for whitening teeth. They are thin, flexible strips coated with a whitening gel containing peroxide. When applied to the teeth, the gel gradually whitens the enamel.
To find FDA-approved teeth whitening strips, you can check the FDA's website or consult with us who can guide you to approved and reputable brands. It's also a good idea to read product labels and reviews to ensure you are purchasing a safe and effective product.
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