FDA Certificate

FDA continues its work throughout every corner of the United States regarding new human and animal drugs, medical devices, food additives, and infant formulas. FDA also monitors the production, import, transport, storage, and sale of products worth one trillion dollars annually.

After a public health disaster in 1937, the realization that there should be a stronger federal law in the USA arose. Sulfanilamide, which was used in the treatment of some diseases like sore throat and gonorrhea and was called the first “wonder drug,” was used in children. However, as a result of the inclusion of a poison also used in antifreezes in the liquid drug, 107 people, mostly children, lost their lives.

Previous laws did not require drug manufacturers to test the drug before putting it on the market. The U.S. Congress corrected this law the following year, making it mandatory for companies to prove the safety of new drugs. The new law also included regulations for cosmetics and therapeutic devices.

Over time, it became one of FDA’s responsibilities to monitor that drugs and devices are proven to be effective as well as safe before they are offered for sale. FDA’s role today includes a blend of law and science for the protection of consumers.

Considering that American people spend more than 20 percent of their income on products under FDA’s responsibility, it is seen that the decisions made by the institution directly affect every American citizen. Determining “prevention” as the first priority in terms of public health, FDA monitors food imported into the country for the consumption of safe food by the public, and prevention strategies are determined through scientific research and risk assessment.

Performing more than 15 thousand control studies every year in terms of the safety of medical products, FDA is always prepared against the emergence of unexpected health risks and makes timely interventions on site. One of the institution’s priorities is expressed as ensuring easy access for the public by offering new technologies to the market.

As one of the oldest and most respected consumer protection organizations in the USA, FDA’s principles include the use of state-of-the-art technology, acting on a universal scale due to products being marketed worldwide, making decisions where all stages of the product including pre-market and post-market are considered, and cooperating with all relevant sectors for prevention studies.

For more information about the FDA Certificate, you can fill out the contact form in the contact section, send an e-mail to info@medicert.com.tr, or reach us at our phone number +90 232 327 33 44.

Under the US Bio-terrorism Act, domestic and foreign food facilities must register their production, production processes, and product packaging with the U.S. FDA. Food facilities, operators, or agents involved in interstate food trade must also register with FDA.

For foreign food facilities, registration must be completed before products are exported to the USA. Food facilities involved in production, packaging, and further processing must also be registered with the FDA. Manufacturers of acidified and low-acid foods, canning manufacturers, and dietary supplements also require FDA food facility registration (FCE).

U.S. FDA Food registration is mandatory for all establishments producing food products in the US or bringing food products via export. Companies exporting products to the US must also designate a representative in the US for FDA registration.

As Medicert International Certification, we assist you in all your FDA processes, including appointing a representative for your company’s American FDA procedures.

Under the Bioterrorism Act, all US and foreign food companies that manufacture, process, pack, or hold food for consumption in the United States must register with the FDA. Products imported from companies that do not perform FDA registration will be detained at the port of entry and will not be allowed to enter the United States.

Information required during registration includes: Name and address of the facility (and parent company if applicable), name and contact details of the owner or authorized representative, all trade names used by the facility, product categories, and a declaration that information is true and accurate. Foreign companies must provide the name and contact details of their U.S. agent.

Articles considered food under this act include: Baby food, beverages, fruits and vegetables, dairy products and eggs, fish and seafood, raw agricultural products used as food, bakery products, canned and frozen foods, snacks and sweets (including gum), live food animals, pet food, and animal feed.

Exemptions: Private residences used for food processing but serve as homes, establishments distributing non-bottled drinking water, farms, transport vehicles, retail food establishments (like supermarkets), restaurants, nonprofit food facilities, fishing vessels, and facilities inspected by the US Department of Agriculture (USDA) for poultry, meat, and eggs are not required to register.

The US Food and Drug Administration (FDA) is responsible for regulating medical devices including surgical masks, face shields, respirators, gowns, and gloves used to diagnose, prevent, and treat COVID-19 such as diagnostic tests, ventilators, and personal protective equipment (PPE).

FDA is committed to ensuring that patients and healthcare professionals have timely and continuous access to high-quality diagnostic and therapeutic medical devices to respond effectively to the COVID-19 pandemic.

In Vitro Diagnostic Tests: COVID-19 Tests including Antibody Tests. In vitro diagnostics are tests performed on samples taken from the human body, such as mucus taken from the nose or throat, or blood taken by a finger prick or a phlebotomist. In vitro diagnostics can detect diseases or other conditions and be used to monitor a person’s overall health to help cure, treat, or prevent diseases. Patients and their doctors rely on the FDA to ensure that the in vitro diagnostics they use to make medical decisions are accurate, reliable, and clinically meaningful.

Under the Bioterrorism Act, starting from December 12, 2003, food products to be imported to the USA must be notified electronically to the FDA before arrival to receive a confirmation number. This notification can be made by a customs broker, importer, US agent, or any person with knowledge of the imported products.

Products that have not been notified in advance or have been notified incompletely will not be allowed for import and will be held at the port or in a secure warehouse. Notification can be made through the Automated Broker Interface or the FDA Prior Notice system.

Required information includes: Notifier details, person providing information (if different), product names and quantities, manufacturer details, country of production, carrier details, country of loading, estimated arrival date and place, importer details, firm performing subsequent transport, and coordinate shipment details. Any changes in these details after notification require a new submission.

For medical devices, FDA has established a system of approximately 1,700 generic classifications grouped into 16 medical specialties. Each type of device is assigned to one of three regulatory classes based on the level of control necessary to ensure the safety and effectiveness of the device.