FDA certification is considered one of the most prestigious certifications not only in the United States but also worldwide. You can easily find this certification on products across a wide range of industries and sectors. But what exactly is the FDA? What assurances does this certification provide to consumers? All will be revealed in the following article.
Overview of the FDA
The FDA (Food and Drug Administration), or the U.S. Food and Drug Administration, is a federal agency under the U.S. Department of Health and Human Services. This agency was established in 1906 in Maryland with the purpose of regulating food and pharmaceuticals in the United States. Therefore, any product or service in the above fields that wants to appear in this market needs to have this specific certification.
Currently, the FDA has approximately 223 offices and 13 laboratories across the United States. With the strong growth of the import-export market and the increasing demand for certification worldwide, the organization has also opened offices in many countries around the world, such as India, the United Kingdom, China, Chile, etc.
Scope of FDA certification
It can be said that FDA certification is essentially a “visa” for products or services related to food and pharmaceuticals to enter the US. This review process aims to ensure product safety and, through that, achieve the goal of protecting the health of consumers. The following items fall within the scope of this certification:
_ Food & beverage group: Food, functional foods, dietary supplements.
_ Pharmaceutical group: Prescription or non-prescription drugs, tobacco, vaccines, blood transfusion products, cosmetics and beauty products, veterinary products.
_ Devices: Medical devices, electromagnetic radiation devices, veterinary products.
FDA Evaluation Standards
Due to its close connection to public health, FDA evaluation standards are considered relatively strict, with diverse standards for products in different fields. The most important include:
_ Food & Beverage Group:
FDA 21 CFR (110&117): Good Manufacturing Practices (GMP) standards for food.
FDA FSMA (Food Safety Modernization Act): Food safety modernization law aimed at minimizing the risk of food contamination.
_ Healthcare Group:
FDA 21 CFR (210&211): GMP standards for pharmaceutical manufacturing.
FDA OTC Monograph: Regulations for over-the-counter (OTC) drugs.
_ Equipment Group:
FDA 21 CFR Part 820: Quality management standards for medical devices.
FDA 510(k) Clearance: Requirements for medical devices that need to be approved before distribution.
In addition, it should be noted that this certification is granted for each product, meaning that businesses need to register each product separately. However, this certification does not specify limits on the quantity or weight of products.
Benefits of FDA certification
The US is undoubtedly one of the strongest markets in the world today, where goods almost always generate large profits. Therefore, obtaining certification is extremely important. The FDA will help a company’s products pass smoothly through the US market because without this certification, the products will be destroyed immediately.
Moreover, FDA certification is widely trusted not only in the U.S. but also globally. A product with this certification signifies that it has successfully passed rigorous evaluations, ensuring consumer safety. This helps the product gain customer trust while enhancing the reputation of the business and manufacturer.
Conclusion
As the economy continues to grow rapidly, FDA certification and its rigorous evaluations are increasingly trusted by consumers worldwide. Products and brands with this certification are also gradually gaining favor. FDA certification is not just a standard certification; it also provides consumers with health assurances and enhances the reputation and credibility of businesses.