FDA is the United States Food and Drug Administration. It is one of the executive agencies established by the U.S. government within the Department of Public Health (PHS) within the Department of Health and Human Services (DHHS). Responsibility is to ensure the safety of food, cosmetics, drugs, biologics, medical equipment, and radioactive products produced or imported into the United States. FDA is mainly divided into two parts: testing and registration. Medical devices, cosmetics, food and drug products require FDA registration.
一 What types of products are FDA responsible for?
Supervision and inspection of food, drugs (including veterinary drugs), medical devices, food additives, cosmetics, animal food and drugs, wine beverages with alcohol content below 7%, and electronic products; ions and non-ions generated during the use or consumption of products Testing, inspection and certification of radiation effects on human health and safety.
The FDA international free sales license is not only the highest level of certification in the US FDA certification, but also the most common certification for food and drugs approved by the World Trade Organization (WTO). It is the only one that must be fully approved by the US FDA and the World Trade Organization before it can be issued. certification certificate. Once this certification is obtained, the product can enter any WTO member country smoothly, and even the marketing model, the government of the country where it is located is not allowed to interfere.
二 What is the difference between FDA testing, FDA registration, and FDA certification?
• FDA testing
Generally, for products under controlled categories such as food contact materials (such as water cups, baby bottles, tableware, etc.), cosmetics, drugs, etc., an FDA test report is also required to show that the product meets quality requirements. FDA testing is a registration or registration, and no certificate is issued.
• FDA registration
FDA registration actually adopts the integrity declaration model, that is, manufacturers are responsible for their products meeting relevant standards and safety requirements, and registering on the US federal website. If something goes wrong with the product, they must bear corresponding responsibilities. Therefore, for most products registered by FDA, there is no need to send samples for testing and no certificates are issued.
• FDA certification
Strictly speaking, there is no FDA certification. This is a common saying. It is actually a collective name for FDA testing and FDA registration, both of which can be called FDA certification.
三 Does Amazon want FDA certification or FDA registration?
It is mainly determined based on the seller’s products. When listing product categories such as food contact materials (kitchenware, water cups, baby bottles, etc.), cosmetics, medicines, and health products on Amazon's US site, you generally need to provide an FDA test report. Just find a third-party testing agency recognized by Amazon to make relevant reports.
For companies exporting food, drugs and medical devices to the United States, they must register with the FDA and list the company and products, otherwise the customs will not clear the goods. It is a mandatory requirement.
四 What are the common product categories on the Amazon platform?
1.Food FDA registration
Types of products for human consumption include alcohol, confectionery products, beverages, candies, cereals, cheese, chocolate or cocoa, coffee or tea, food colorings, regular diet or meal replacements including medicated foods, functional foods (including Chinese herbal medicines) , condiments, aquatic products, food additives, sweeteners, fruits and their products, gels, ice cream, imitation dairy products, pasta, meat, milk, broth or jam, nuts, eggs, vegetables and their products, vegetable oil, simulated meat, flour or starch, etc. Animal foods include: cereals, oil seeds, alfalfa, amino acids, animal products, brewed products, preservatives, citrus products, distilled products, enzymes, oils, fermented products, aquatic products, dairy products, minerals, Molasses, non-protein nitrogen products, peanut products, animal waste recycled products, screening chips, vitamins, yeast, pet food, etc.
These food companies must submit registration to the US FDA to obtain an FFRN (Food Facility Registration Number) number and PIN. When filing for registration, a person living in the United States must be designated as the U.S. agent.
At the same time, every two years, the original FDA registration number needs to be updated between 12:01 am on October 1 and 11:59 pm on December 31 of the year ending in an even number, otherwise the original registration number will become invalid.
For low-acid canned and acidified foods, in addition to registering with the FDA to obtain an FFRN number and PIN, they must also declare their processing process to obtain a Submission Identifier (SID number).
For health food, in addition to registering with the FDA to obtain the FFRN number and PIN, health products also need to make functional claims. Companies need to submit the functional claims to the FDA for review and filing within 30 days after the product is launched.
Egg-laying farms, in accordance with the requirements of regulation 21 CFR 118.1 (a), have more than 3,000 hens and do not sell eggs directly to consumers, and must register with the FDA as an enterprise. Enterprises must first register with the Food Enterprise FDA in accordance with the requirements of ordinary food enterprises, in addition to the FFRN number and PIN, and then register the egg farm (Shell Egg Producer Registration) number.
When food is listed on the Amazon platform, you will be asked to provide these registration numbers.
2.cosmetic
According to the US FDA cosmetics regulations and voluntary requirements for cosmetics registration, cosmetics companies can register cosmetics through the electronic system VCRP or submit paper documents before or after the product is launched in the United States. After registration, the company will have a business registration (registration number), and product formula number (CPIS). The information the company needs to provide includes company information (such as name, address, person in charge, contact information, etc.), product information (such as trademark, formula, raw material CAS number, etc.) .
When cosmetics are put on the Amazon platform, you will be asked to provide these registration numbers.
3.medical instruments
The U.S. FDA divides medical devices into three levels: Class I, Class II, and Class III according to the level of risk.
Class l products are low-risk products, and most Class I products are 510K exempt products. As long as companies register their companies and product listings with the FDA, and obtain a registration number, the products can be put on the market.
Such as most surgical instruments, stethoscopes, medical equipment, surgical gowns, surgical caps, masks, urine collection bags, etc.
Class II products are medium-risk products. Most Class II products need to apply for FDA 510K to be put on the market. After obtaining the 510K number, the enterprise registration and product listing are carried out. After obtaining the registration number, they can be put on the market (detailed introduction in point 5 below);
Such as thermometers, blood pressure monitors, hearing aids, oxygen concentrators, condoms, acupuncture needles, electrocardiographic diagnostic equipment, non-invasive monitoring equipment, optical endoscopes, portable ultrasonic diagnostic equipment, fully automatic biochemical analyzers, constant temperature incubators, comprehensive dental treatment instrument, medical absorbent cotton, medical absorbent gauze, etc.
Class III has the highest risk level. Most Class III products must apply for a PMA before being put on the market. The product must undergo clinical trials. After the product obtains the PMA number, the company must be registered and the product shall be listed. After obtaining the registration number, it can be put on the market;
Such as implantable pacemakers, extracorporeal shock wave lithotripsy, invasive patient monitoring systems, intraocular lenses, invasive endoscopes, ultrasonic scalpels, color ultrasound imaging equipment, laser surgery equipment, high-frequency electrosurgery, microwave treatment Instruments, medical MRI equipment, Sexual use of infusion sets, blood transfusion sets, CT equipment, etc.
When medical products are listed on the Amazon platform, they will be required to provide a registration number.
4.Drugs
The FDA has a complete set of certification procedures for pharmaceutical products to ensure the safety and effectiveness of new drugs. The more common one is to focus on OTC drugs and register NDC (National Drug Verification Number).
5.What is a 510(k)? How to do?
If the product is determined to be a Class II medical device, a 510(k) filing is required.
The 510(k) document is a pre-market application document submitted to the FDA. The purpose is to prove that the device applied for marketing is as safe and effective as a legally marketed device that is not affected by pre-market approval (PMA), that is, it is an equivalent device (substantially equivalent). The applicant must compare the device applied for marketing with one or more similar devices currently on the U.S. market, and draw and support the conclusion that the device is equivalent.
五 What information is needed to apply for a 510(k) file?
01 Application letter
Including the basic information of the applicant (or contact person) and the company, the purpose of 510(K) submission, the name, model and classification information of the device applied for listing, the name of the product (Predicate Device) for substantial equivalence comparison and its 510(K) Number;
02 Catalog
That is, a list of all information contained in the 510(k) file (including attachments);
03 Authenticity Guarantee Statement
FDA can issue standard samples;
04 Equipment name
That is, the product’s common name, FDA classification name, and product trade name;
05 Registration number
If the company has registered the company when submitting the 510(K), the registration information should be given. If it is not registered, it should also be noted;
06 Category
That is, the classification group, category, management number and product code of the product;
07 Performance Standards
Performance standards, mandatory or voluntary standards that a product meets;
08 Product identification
Including corporate packaging logos, instructions for use, packaging accessories, product labels, etc.;
09 SE
substantial equality comparison;
10 Statement
510(k) Summary or Statement;
11 Product Description
Including the product’s intended use, working principle, power source, components, photos, process drawings, assembly drawings, structural schematics, etc.;
12 Safe and effective
Product safety and effectiveness, including various design and testing data;
13 routine tests
Biocompatibility; product performance;
14 applicable
Color additives (if applicable);
Software verification (if applicable);
15 Sterilization
Sterilization (if applicable), including description of sterilization method, sterilization verification product packaging and labeling, etc.
It can be seen that the 510(k) application process for Class II medical device products is very long, taking nearly half a year. The products we generally apply for FDA registration belong to Category 1, Category 2 requires applying for 510(k), and Category 3 is more difficult.
六 What are the frequently asked questions about FDA registration?
• Which agency issues the FDA certificate?
Answer: FDA registration does not have a certificate. The product will obtain a registration number by registering with the FDA. The FDA will give the applicant a reply letter (with the signature of the FDA chief executive), but there is no FDA certificate.
• Does FDA require designated certified laboratory testing?
Answer: FDA is a law enforcement agency, not a service agency. FDA has neither public-facing service certification agencies nor laboratories, nor does it have a “designated laboratory”. As a federal law enforcement agency, the FDA cannot engage in such matters as both a referee and an athlete. FDA will only recognize the GMP quality of service testing laboratories and issue certificates of conformity to qualified ones, but it will not "designate" or recommend a specific laboratory or laboratories to the public.
• Does FDA registration require a US agent?
Answer: Yes, Chinese applicants must appoint a U.S. citizen (company/society) as their agent when registering with the FDA. The agent is responsible for performing process services in the United States and is the intermediary between FDA and the applicant.
• How long is the FDA registration number valid for?
Answer: There is no validity period for U.S. food grade reports. The prerequisite for re-applying for a report is that the product needs to be re-submitted for testing if the product material changes or regulations are updated.
The validity period of FDA registration for medical devices is generally one year, with October 1st of each year as the boundary. If it is applied before October 1st, you need to pay a renewal fee between October and December. If it is applied after October 1st, it must be renewed by the following month. The registration fee must be paid between October and December of a year for renewal. If the fee is not paid by the expiration date, the registration will become invalid.
• What are the consequences of not having an FDA registration number?
Answer: The biggest impact is that if the platform finds out, it will directly cancel its sales permission; secondly, the FDA generally conducts random inspections on food, drugs, and cosmetics entering the United States (the random inspection rate is 3-5%). If the random inspection samples are qualified, the batch of products can be released; if the random inspection samples are unqualified, the batch will be "detained".
If the problems discovered during the inspection are general problems (such as unqualified trademarks, etc.), the importer can be allowed to handle it locally and then release it after passing the re-inspection; but if the problems discovered during the inspection are related to health quality and safety, then No release is allowed. It needs to be destroyed locally or transported back to the exporting country by the importer, and cannot be transferred to other countries. In addition to random inspections, the FDA also has a measure, that is, imported products with potential problems must be inspected batch by batch (rather than random inspections) when entering the customs, which is an "automatic detention" measure.
Post time: Dec-22-2023