Hello, FDA is the abbreviation of U.S. Food and Drug Administration (Food and Drug Administration).
FDA's responsibility is to ensure the safety of food, cosmetics, drugs, biological agents, equipment and radiological products produced or imported into the U.S. The FDA-approved food, cosmetics and medical devices are guaranteed to be safe and effective for humans. In the United States and nearly 100 other countries, only FDA-approved materials, devices and technologies can be commercialized for clinical use.
The U.S. FDA registration covers cosmetics, food, medical devices, pharmaceuticals, lasers and other products for registration. According to the regulations, food, drugs (including veterinary drugs), medical devices, food additives, cosmetics, animal food and drugs, wine beverages with an alcohol content of less than 7%, and electronic products such as lasers must be tested by the FDA to prove that they are safe before they can be sold on the market.
Graphic Bug Creations
I) FDA Registration of Cosmetics
Any cosmetic product marketed in the United States, whether locally manufactured or imported from a foreign country, must comply with the Federal Food, Drug, and Cosmetic Act , the Fair Packaging and Labeling Act, and regulations promulgated by the governing boards of these laws.
What cosmetics require FDA registration?
The Federal Food, Drug, and Cosmetic Act defines a cosmetic product as an article used exclusively on the human body for the purpose of cleansing, beautifying, enhancing the attractiveness of, or altering the appearance of the human body without affecting the structure or function of the body. Products that fall under this definition are skin creams, lotions, perfumes, lipsticks, nail polishes, eye and face creams, shampoos, permanent curlers, hair dyes, toothpastes, deodorants and any ingredient used as part of a cosmetic product. All of these products require an FDA registration.
FDA Voluntary Cosmetic Registration Program (VCRP)
The FDA Voluntary Cosmetic Registration Program (VCRP) is available to manufacturers, packagers, and distributors of cosmetic products marketed in the U.S. for submission of cosmetic company registration information (Form FDA 2511) and product filing information (Form FDA 2512).
The VCRP assists FDA in fulfilling its responsibility to regulate cosmetics. FDA uses this information to evaluate cosmetic products in the marketplace.
II) FDA Registration of Food Contact Products
Food companies outside of the United States are required to register with FDA before exporting to the United States,? And in the export to the FDA for cargo notification. Imported food products are subject to FDA inspection when imported into the U.S. ports of entry, and if the shipment is found to be non-compliant with U.S. requirements, the FDA may detain the imported product.
Food contact materials refer to all materials used in the processing and production of packaging storage and transportation of food and food can come into contact with the process.
Common materials include a variety of plastic metal ceramic glass bamboo and wood products. For example, drinking cups, plastic lunch boxes, plastic spoons and so on.
These and food can come into contact with the environmental safety of the material directly related to the user's dietary safety and health, so the export of such products to the U.S. needs to be in accordance with FDA standards for the relevant testing and certification.
Three laser products FDA registration
The U.S. Food and Drug Administration (FDA) regulates and manages all laser products sold in the United States. Manufacturers must certify that their laser products comply with U.S. federal regulations and laser performance standards [21 CFR 1040.10 and 1040.11]. The laser performance standards apply to all laser products sold in the United States [21 CFR 1040.10(a)].
FDA Registration of Laser Products:
Laser products requiring FDA registration include: laser pointers, laser presentations, laser displays, products containing laser units (CD players, DVDs, CD-ROMs, laser printers, etc.) safety protection and rescue products.
D) FDA Registration for Drug Companies
Section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires companies that manufacture, prepare, distribute, compound, or process drugs in the U.S., or that offer to import drugs into the U.S., to register with the FDA.
These domestic and foreign companies must list all drugs manufactured, prepared, disseminated, compounded, or processed for commercial sale in the United States at the time of registration. In addition, foreign organizations must name U.S. agents and importers in their registrations.
FDA Registration Instructions for Drug Companies
With certain exemptions, any establishment engaged in the manufacture, repackaging, relabeling, or recall of a drug product is required to register with the FDA. Registration is required within 5 days of introducing a product into commercial distribution. Annual renewal of registration must occur between October 1 and December 31 of each year.
Drug Company FDA Registration Requirements
Drug manufacturers and private label drug distributors submit company registration and drug registration data electronically using the Structured Product Labeling format (SPL).
The requirements for business registration and drug registration are set forth in Section 510 of the "Federal Food, Drug, and Cosmetic Act" and Title 21 of the Code of Federal Regulations (CFR) Part 207 (21 CFR 207), which was amended in 2016 amended and became effective on November 29 of the same year.
FDA Drug Registration Targets
All registered drug companies must list all products they manufacture for commercial distribution under their own labeling code. This includes API manufacturers, other bulk manufacturers, contract manufacturers, repackagers and relabelers.
Timing of FDA drug registrations
Initial product registrations should be submitted within three days of a company's initial registration.The FDA recommends that listing data should be updated in a timely manner. However, no later than June or December is required following changes in information. For products that are not required to be updated, companies can submit a no-information-change affirmation once a year during the Oct. 1 to Dec. 31 update period.
V) Medical Device FDA Registration
The FDA regulates medical devices through the Center for Devices and Radiological Health (CDRH), which oversees the manufacturing, packaging, and distributing of medical devices to comply with the laws under which they operate.
If the product is a novel invention that does not exist in the marketplace, the FDA requires manufacturers to conduct rigorous human trials with compelling medical and statistical evidence of the product's effectiveness and safety.
What medical devices require FDA approval?
The FDA has a clear and strict definition of a medical device: "A medical device is an instrument, apparatus, tool, machine, appliance, insertion tube, in vitro reagent, and other related article, including a component, part, or accessory, which is clearly listed in the National Form. >: are expressly listed in the National Formulary or the Unite States Pharmacopeia, or in the appendices to either; are intended for use in the diagnosis of disease or other physical conditions in animals or humans, or in the cure, mitigation, or treatment of disease; and are intended to affect the function or structure of the body of an animal or a human being, but are not metabolized for their primary purpose". primary purpose".
Additionally, not only are all kinds of instruments and tools used in hospitals, but also eyeglass frames, eyeglass lenses, toothbrushes, and massagers that consumers can buy in general stores fall under the scope of the FDA's regulation.
FDA Classification of Medical Devices
The FDA classifies medical devices into three categories (I, II, and III) according to their risk level, with Class III being the highest, and the higher the category, the more oversight is provided.
The FDA specifies the product classification and management requirements for each type of medical device, and the FDA's Medical Device Catalog includes more than 1,700 products.
Any medical device that wants to enter the U.S. market must first be clear about the product classification and regulatory requirements.
Of course, Piggyback has a branch in the U.S. to handle, in addition to the five categories of products listed above, other products also do the U.S. FDA registration, if you have any questions, welcome to the eight ring at any time to consult with the Oh