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What is the FDA ?

  Affiliated to the United States Department of Health; It is the office responsible for food, dietary supplements, medicine, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary instruments and cosmetics. FDA stands for U.S. Pat. It is a Food and Drug Administration and can be expressed as the "American Food and Drug Administration" in Turkish. Institute of Public Health this mission in our country and Turkey pharmaceuticals and medical devices agency (TİTCK) plays. FDA, which consists of 9 sub-units such as Drug Evaluation and Research Center, Food Health and Nutrition Center, Medical Devices and Radiology Research Center; It is a globally accepted and respected inspection authority in its field. The foundation, which dates back to 1906, has a long history of 110 years. The purpose of the establishment of this department is to protect public health by presenting its scientific and comprehensive research to the public in order to provide the highest quality products necessary for health and life.

Why is FDA Approval Important ?

  The FDA continues to work on newly produced human and animal medicines, medical devices, food additives and baby food in every corner of the USA. The FDA also monitors the manufacture, import, shipping, storage and sale of products worth one trillion dollars annually.

  After a public health disaster in 1937, it was realized that there should be a stronger federal law in the USA. Sulfanilamide, which was used in the treatment of some diseases such as throat burning and gonorrhea and was called the first "miracle drug", was used in children. However, as a result of the presence of a poison used in antifreeze in the liquid form of the drug, 107 people died, most of them children.

  Previous laws did not require drug manufacturers to test the drug before placing it on the market. The US Congress revised this law the following year, requiring companies to prove the safety of new drugs. The new law also included regulations for cosmetic and therapeutic devices.

  Over time, it was also among the responsibilities of the FDA to monitor the proof that drugs and devices are as effective as they are safe before they are put on the market. The FDA's role today involves making a good blend of law and science for consumer protection.

  Considering that the safety and benefits of the products on which the American people spend more than 20 percent of their income are the responsibility of the FDA, it seems that the decisions made by the institution directly affect every American citizen. Determining “prevention” as the first priority for public health, the FDA monitors the foods imported into the country for the consumption of safe foods and determines prevention strategies through scientific research and risk assessment.

  The FDA, which conducts more than 15 thousand control studies on the safety of medical products every year, is always prepared for the emergence of unexpected health risks, and intervenes in place and on time. One of the priorities of the institution is expressed as the introduction of new technologies to the market and ensuring easy access to the public.

  Among the principles of the FDA, one of the oldest and most respected consumer protection organizations in the USA, the use of the latest technology, acting on a universal scale due to the worldwide marketing of products, making decisions that take all phases of the product into account, including pre-market and post-market, and all Cooperation with relevant sectors is shown.

FDA and Its Effect

  The FDA has been maintaining its influence on the American consumer for a century. One of his most famous achievements was the rejection of thalidomide, a widely used drug that was later revealed to cause significant birth defects. Medicine; It was marketed in Europe in the late 1950s as a way to suppress morning sickness in pregnant women. Doctors at that time thought that the drugs given to the mother could not affect the fetuses. Thus, no attempt has been made to test its safety for developing babies. When thalidomide producers tried to get FDA approval to sell drugs in the US in 1960, FDA inspector Frances Kelsey slowed the process by demanding that the company do more safety work. The following year, reports of thousands of babies born with serious birth defects began to emerge. This incident increased confidence in the FDA and encouraged the transition of changes that strengthen the FDA's drug review process.

FDA and Coronavirus

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

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

In Vitro Diagnostic Tests: COVID-19 Tests Including Antibody Tests

  In vitro diagnosis is tests performed on samples taken from the human body, such as mucus glands from the nose or throat, or blood taken from a finger stitch or taken by a phlebotomist. In vitro diagnosis can detect diseases or other conditions and can be used to monitor a person's overall health to cure, treat, or prevent diseases. Patients and their doctors rely on the FDA to ensure that the in vitro diagnoses they use to make medical decisions are accurate, reliable, and clinically meaningful.

  On February 4, 2020, the Secretary of Health and Human Services (HHS) determined that there is a public health emergency and conditions exist that justify authorization for immediate use of in vitro diagnosis of the novel coronavirus (2019) (2019 -ncov). Rapid detection of COVID-19 cases in the United States requires extensive diagnostic tests to check for the emergence of this rapidly spreading, serious disease.

How FDA Registration Processes Are Done?

  How does FDA registration work? If we express why FDA registration is necessary before the subject: In accordance with the bioterrorism law, all US and foreign food companies that manufacture, produce, pack or store animal and human food for consumption in the USA must register with the FDA. Products imported from companies that do not register with FDA will be taken to the USA at the transit port and will not be allowed to enter the USA.

  Information required during registration; the name, address of the company (and the parent company, if any), the name, address and telephone number of the owner of the telephone number, the owner of the company or authorized representative, all the commercial titles used by the company, the product categories subject to the operation, the statement that the information conveyed by the person who filled the form is true and correct, foreign The name, address, phone number of the US representative of the companies and the phone number of the US representative or another designated person in order to be reached in case of emergency. Apart from this mandatory information, other information may be provided on request.

  Food, baby food, drinks, fruits and vegetables, dairy products and eggs, fish and seafood, uncooked agricultural products used as food, bakery products, canned and frozen foods, cookies and candies (chewing gum including), live food animals, pets, animal food and food.

  In accordance with the relevant regulation, houses that are processed or manufactured, packaged or stored and used as residences, organizations that distribute non-bottled drinking water, farms, transport vehicles carrying food, retail food businesses (such as markets), restaurants, non-profit food companies, fishing gear, poultry, meat and egg companies inspected by the US Department of Agriculture are not required to register.

  If a food product manufactured, packaged or stored by a foreign company is imported to the United States through another foreign company, the first foreign company is not obliged to register, but if the second company only carries out a small amount of activity (such as sticking labels) must also register.

FDA Forwarding of Food Products to be Imported

  In accordance with the Bioterrorism Act, the above-mentioned food products to be imported into the USA starting from December 12 of 2003 are notified electronically by the customs broker, importer or US agent or any person who has information about the products to be imported and notified from the FDA. It is required to obtain a confirmation number. According to this notification, FDA will decide whether the products to be imported will be examined or not.

  Products that have never been notified in advance or whose notification has been made incompletely will not be allowed to be imported into the USA and these products will be stored at the port or in a secure warehouse. The notification process can be realized through the Automatic Customs Broker interface or the Automatic Commercial System with FDA prior notification.

  The name, telephone, e-mail address, fax number, company name and address of the person making the notification during advance notification; In case the person transmitting the information and the person providing the information are different, the name of the person who transmitted the information, telephone, e-mail address, fax number, company name and address, the name and quantity of the products, if the identity information of the manufacturer is related to the carrier of the country from which the identity information of the manufacturer is obtained. information about the country where the products are loaded, the estimated arrival date and location of the products, information about the company that will carry out the transportation process after the importer is received, how the products will be transported and the coordinated shipment information must be provided. If any of this information changes after the notification is made, a new notification must be made.

  Food products brought with them for private consumption purposes other than commercial purposes, food products that do not leave the destination port until they are exported to another country, meat, poultry and egg products applied by the US Department of Agriculture are Food products manufactured at home and sent as gifts to someone living in the United States for personal consumption are excluded from the prior notification obligation.

FDA Food Registration

  As FDA food registry record, in accordance with the US Bio-terrorism law, domestic and foreign food facilities are required to register the production, production process and product package with the US FDA. Food and inter-state food trade, which is also required for domestic or foreign food facility officials, animal owners, operators or agents, must also be registered with the FDA.

  If the FDA food registry is foreign foods, only before they are exported to the USA, they have to pass through this facility and register with the FDA in the USA, such as production, product packaging and foreign food facilities, which are advanced application processes of food by other foreign food facilities. At the same time, food facilities must register their products that require US FDA registration. Acidified and acidic food manufacturers, canned food manufacturers, food supplements also require FDA food registration (FCE) process.

US Representative Service for FDA Registration

  With the US agency service for FDA registration, the US FDA Food registration process is mandatory for all organizations that bring food products produced in the US or export food products. Firms exporting products to the USA must also specify a representative to the USA for FDA registration.

  As Medicert International Certification, we assist your company in all FDA transactions, including assigning representatives for your US FDA transactions.

FDA Registration in Medical Devices

With FDA registration in medical devices, the food and drug administration has established a system of approximately 1700 different generalizing classifications of devices and grouped them into 16 medical features, named in plate form. Each comprehensive type of devices assigns one of three regulation classes, based on the level of control required to ensure the efficiency and safety of the device.

Device Class and Regulations controls

• Class 1 General Controls
• Class 2 General Controls and Special Controls
• Class 3 General Controls and Pre-Market Approval

The federal food and cosmetic law defines a medical device including an instrument, apparatus, hardware, machinery, any component, part, and accessory.

These;

• It is defined in the national formula booklet and either in the US pharmacopoeia or in any supplement thereof.
• It is intended for use in the diagnosis of disease or the treatment, alleviation, amelioration or prevention of disease in humans or animals.
• It is designed to influence the structure or any process of the human or animal body, which cannot achieve its primary intended purpose by means of chemicals in or on human or animal bodies, and this does not depend on whether it has been metabolized for the achievement of primary intended purposes.

FDA-related important Links

GENERAL GUIDELINES (Guidance Documents)

http://www.fda.gov/cder/guidance/index.htm

FDA GMP GUIDE (Current Good Manufacturing Practice - cGMP Regulations)

http://www.fda.gov/cder/dmpq/

FDA Approved Drugs (Search Engine)

http://www.fda.gov/cder/ob/default.htm

PATENT (Patent Term Extension and New Patents Docket Number * 95S-117)

http://www.fda.gov/cder/orange/21bookpub.pdf

GMP (Current Good Manufacturing Practice Issues on Human Use Pharmaceuticals)

http://www.fda.gov/cder/dmpq/cgmpnotes.htm

Dyestuffs (Coloring matters FDA)

http://www.cfsan.fda.gov/~dms/opa-col2.html

Recall and Reliability Alerts (Product Safety and Recalls)

http://www.fda.gov/opacom/7alerts.html

FDA Inspectors Inspection Guides

http://www.fda.gov/ora/inspect_ref/igs/iglist.html

Guidelines Prepared by FDA / CDER (Guidance CDER is Planning to Develop)

http://www.fda.gov/cder/guidance/guidance-agenda.htm

FDA/Drug Master Files

http://www.fda.gov/cder/dmf/index.htm

FDA’ den Tüketiciler İçin İlaç bilgileri (Consumer Drug Information)

http://www.fda.gov/cder/drug/default.htm#Consumer Drug Information