What is the FDA? FDA is a globally recognized organization that is the Food and Drug Administration under the US Department of Health. The FDA, which works under the Ministry of Health of the United States of America, is important for many companies in the food and pharmaceutical industry. This institution works as an office responsible for dietary supplements, medicines, food products, blood products, biological products, cosmetic products, tobacco products, medical products, radiation-emitting instruments, medical devices, vehicles, and veterinary instruments. The documents and certificates issued by this organization are called FDA certificates. The organization makes certain regulations regarding these products' production, sale, import, and export.

What is the FDA?

FDA is one of the leading institutions in the world with various product groups such as food and medicine. Established to protect public health, this organization aims to ensure that the products under its scope are used safely in accordance with the requirements published by this unit. This institution, which was basically established for US public health, works to ensure that all products that will enter the US food market are free from elements that threaten public health. The scope of authority of this institution is also quite broad. FDA's standards, product approvals and studies are accepted as references in many places. This organization never allows products under its responsibility that have not received the necessary FDA approval to enter the US market.

The FDA is considered to be the biggest regulator of the pharmaceutical industry, not only in the US but all over the world. This institution, which is the biggest boss of the food industry as well as the pharmaceutical industry that kept the US afloat during the global crisis, has always been at the center of great debates with the decisions it makes and does not make. As we read about the process that led to today's FDA, we learn that from 1898 to 1914, the Bayer pharmaceutical company sold heroin as a "non-addictive" (!) painkiller. In other words, many things have changed between then and now.

In addition, the FDA regulates the production, marketing and distribution of tobacco products to reduce tobacco use by young children. This organization sets requirements for the quality of products from all corners of the world and their compliance with the health of living beings. According to the legislation, it is responsible for the entry of products that do not comply with US norms into the country and for taking legal measures against irregularities detected after entry.

Why is FDA Approval Important?

FDA approval shows whether products, such as food, medicine, etc., have a negative impact on human or animal health or whether these effects are acceptable. They state that the benefits of any FDA-approved product always take precedence over its potential risks.  The statements and claims of manufacturers or importers about the product become fully valid with this approval. Some analysis and tests are carried out to obtain this approval. For this reason, it is necessary to work with institutions recognized by the FDA. In addition, the approved products also comply with the criteria such as hygiene and health determined within the scope of FDA approval, and the necessary permits have been obtained.

How to Get FDA Approval?

Before your FDA Registration, you first need to learn what the application does. When we look at the FDA registration, in accordance with bioterrorism laws, all those who manufacture, produce and package human and animal foods intended for consumption in the USA must register with the FDA institution. Any product that is not registered is confiscated.

The most curious question is how to obtain this approval. Obtaining this FDA-compliant certification is a long and comprehensive process.  First of all, it is useful to state this. Companies wishing to obtain FDA-compliant certification should consult with special representative companies and make mutual agreements as a result. Companies that want to obtain this document generally benefit from consultancy services in order to obtain FDA approval. The preparation of the requested documents, the fast operation of the process, and the production of solutions to problems in the process always require labor.

Documents Required for FDA Approval

The required documents for FDA approval depend on the type of product. Generally, documents such as clinical data, manufacturing information, labeling, and quality control records are needed.

Cost of Obtaining FDA Approval

In our article, we mentioned which products are covered by FDA approval. We also noted that the most significant purpose of FDA Approval is to protect the consumer. The companies that issue the FDA Certificate are organization within the American Ministry of Health and are responsible for products such as medical equipment, biomedical instruments, cosmetic products, radiation emitting instruments, veterinary instruments, and blood products, especially food, diet and medicine. If we want to specify the price of the FDA Certificate on average, prices vary between 1000 USD and 1250 USD.

Products Requiring FDA Approval

It can be obtained for various products regulated and inspected by the US Food and Drug Administration (FDA). Here are some examples of the types of products for which an FDA Certificate can be obtained;

Medicines: Prescription or over-the-counter medicines for humans or animals are regulated and approved by the FDA. In this case, new drug application (NDA) or limited review processes may be used for modified forms of existing drugs.

Cosmetics: Cosmetics must be safe and conform to the labeling on the packaging.

Medical Devices: Medical devices include products used to diagnose, treat or protect patients. Medical devices include a wide range of products, from the most straightforward thermometers to advanced medical imaging devices.

Dietary Supplements: Dietary supplements, such as vitamins, minerals and other nutritional supplements, are regulated by the FDA and may require FDA registration for sale.

Food: The FDA regulates the safety and suitability of food consumed in the United States. Food manufacturers, sellers and importers are responsible for FDA accounting and compliance.

Biological products: Biological products are usually produced through biotechnology and used in treatments. The FDA regulates many of these products, such as blood products, vaccines and gene therapy products.

In addition, the FDA regulates other types of products, and there may be specific regulations or requirements for each type of product. To determine whether the FDA regulates your product and whether you can obtain FDA Clearance, it is important to visit the FDA's official website or contact the FDA directly, depending on your product's type and intended use. In order to obtain this approval, you must fulfill the necessary requirements and obtain sufficient information. In order to obtain FDA certification, you can obtain FDA certification with consultancy services when you meet the necessary terms and conditions.