What is FDA?
Why is FDA Approval Important?
In every corner of the US, the FDA continues to monitor newly manufactured human and animal drugs, medical devices, food additives and infant formula. The FDA also monitors the manufacture, import, transportation, storage and sale of products worth more than a trillion dollars annually.
After a public health disaster in 1937, the US realized the need for a stronger federal law. Sulfanilamide, the first so-called “miracle drug” used to treat certain illnesses such as burning throat and gonorrhea, was used in children. However, 107 people, mostly children, died when the liquid form of the drug contained a poison also used in antifreeze.
Previous laws did not require drug manufacturers to test the drug before putting it on the market. The US Congress amended this law the following year, requiring companies to prove the safety of new drugs. The new law also included regulations for cosmetics and therapeutic devices.
Over time, it became the FDA’s responsibility to ensure that drugs and devices are proven to be safe as well as effective before they go on sale. The FDA’s role today involves ensuring that the law and science are well blended to protect consumers.
Given that the FDA is responsible for the safety and efficacy of products on which Americans spend more than 20 percent of their income, its decisions directly affect every American citizen. The FDA, which prioritizes “prevention” as the first priority in public health, monitors the foods imported into the country to ensure that the public consumes safe foods and determines prevention strategies through scientific research and risk assessment.
The FDA conducts more than 15,000 inspections on the safety of medical products every year, and is always prepared for the emergence of unexpected health risks and intervenes in a timely and appropriate manner. One of the priorities of the Agency is to ensure that new technologies are introduced to the market and easily accessible to the public.
As one of the oldest and most respected consumer protection organizations in the US, FDA’s principles include the use of state-of-the-art technology, acting universally as products are marketed worldwide, making decisions that take into account all phases of the product, including pre-market and post-market, and cooperating with all relevant sectors for prevention efforts.
FDA Certificate
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 contact us at +90 232 327 33 44.
FDA Food Registry
As part of the FDA food registry, the US Bioterrorism Act requires domestic and foreign food facilities to register their production, manufacturing process and product packaging with the US FDA. Foods that are also required for domestic or foreign food facility principals, animal-owning consumers, operators or agents, and interstate food commerce are also required to register with the FDA.
Foreign food facilities must also register with the U.S. FDA in the U.S. If the FDA food registry is foreign food, however, foreign food facilities must also register with the U.S. FDA in the U.S. for the manufacturing, product packaging, and further processing of the food by other foreign food facilities that pass through the facility before it is exported to the U.S. Food facilities must also register their products that require registration with the US FDA. Manufacturers of acidified and acidic foods, canned foods, and food supplements also require FDA food registration (FCE).
US Representative Service for FDA Registration
With the US representation service for the FDA registration process, the US FDA Food registration process is mandatory for all organizations that bring food products manufactured in the US or food products through export. Companies exporting products to the USA must also specify a representative in the USA for FDA registration.
As Medicert International Certification, we assist you in all your FDA procedures, including appointing a representative for your company’s US FDA procedures.
How is FDA Registration Procedures Done?
How does FDA registration work? If we express why FDA registration is necessary before the subject: Under the Bioterrorism Act, all US and foreign food companies that manufacture, produce, package or store animal and human food for consumption in the US must register with the FDA. Products imported from companies that do not register with the FDA will be detained at the port of entry into the US and will not be allowed to enter the US.
The information required during registration is the name, address and telephone number of the company (and parent company, if any), the name, address and telephone number of the owner, the name, address and telephone number of the owner or authorized representative of the company, all trade names used by the company, the product categories subject to processing, the statement that the information provided by the person filling out the form is true and correct, the name, address and telephone number of the US representative of foreign companies and the telephone number of the US representative or another designated person for emergency contact. In addition to this mandatory information, other information may be provided upon request.
Foods, baby food, beverages, fruits and vegetables, dairy products and eggs, fish and seafood, uncooked agricultural products used as food, bakery products, canned and frozen foods, snacks and candies (including chewing gum), live food animals, pets, animal food and food.
The relevant regulation does not require registration of homes used as dwellings where food processing or manufacturing, packaging, or storage occurs; establishments that distribute non-bottled drinking water; farms; transportation vehicles transporting food; retail food establishments (such as grocery stores); restaurants; not-for-profit food companies; fishing vessels; and poultry, meat, and egg companies inspected by the US Department of Agriculture.
If a food product manufactured, packaged or stored by one foreign company is imported into the United States through another foreign company, the first foreign company is not required to register, but if the second company performs only minor activities (such as labeling), both companies must register.
FDA and Corona Virus
The US Food and Drug Administration (FDA) is responsible for regulating medical devices such as diagnostic tests, ventilators, and personal protective equipment (PPE) – including surgical masks, face shields, respirators, gowns and gloves – used to diagnose, prevent and treat COVID-19.
The FDA is committed to ensuring that patients and healthcare professionals have timely and continuous access to high-quality diagnostic and therapeutic medical devices to effectively respond to the COVID-19 pandemic.
In Vitro Diognostic Tests: COVID-19 Tests, Including Antibody Tests
In vitro diagnostics are tests performed on samples taken from the human body, such as mucus glands from inside the nose or throat, or blood taken from a finger prick or drawn by a phlebotomist. In vitro diagnostics 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 diagnostics 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 a public health emergency exists and conditions exist that justify authorization for the emergency use of in vitro diagnostics of novel coronavirus (2019) (2019 -ncov). The rapid detection of COVID-19 cases in the United States requires the availability of a wide range of diagnostic tests to control the emergence of this rapidly spreading, serious disease.
Submission of Food Products to be Imported to FDA
Pursuant to the Bioterrorism Act, beginning on December 12, 2003, any of the above food products to be imported into the United States must be electronically notified to the FDA by the customs broker, importer or U.S. agent or any other person with knowledge of the products to be imported and receive a confirmation number from the FDA prior to departure for the United States. Based on this notification, the FDA will decide whether or not to inspect the imported products.
Products that have never been previously notified or that have been incompletely notified will not be allowed to be imported into the US and will be kept at the port or in a secure warehouse. Notification may be made through the Automated Customs Broker interface or through the Automated Commercial System in the form of FDA advance notification.
Name, telephone, e-mail address, fax number, company title and address of the person who made the notification during prior notification; if the person providing the information and the person providing the information are different persons, the name, telephone, e-mail address, fax number, company title and address of the person transmitting the information, the name and quantity of the products, the identification information of the manufacturer, if any, the identification information of the manufacturer, the country of acquisition, information about the transporter, the country where the products are loaded, the estimated date and place of arrival of the products, information about the importer, information about the company that will carry out the transportation process after receipt, how the products will be transported and the coordinated shipment information must be submitted. If there is a change in any of this information after the notification is made, a new notification must be made.
Food products brought by persons arriving in the US for private consumption other than for commercial purposes, food products that do not leave the port of arrival in the US until they are exported to another country, meat, poultry and egg products imposed by the US Department of Agriculture, food products manufactured by a person outside the US at home and sent as a gift to a person living in the US for personal consumption are excluded from the scope of the prior notification obligation.
FDA Registration for Medical Devices
With the FDA registration of medical devices, the Food and Drug Administration has established a system of approximately 1700 different generalized classifications of devices, grouping them into 16 medical specialties, named in the form of sheets. Each comprehensive type of device is assigned to one of three regulatory classes based on the level of control required to ensure the effectiveness and safety of the device.
Device Class and Regulatory Controls
- Class 1 General Controls
- Class 2 General Controls and Special Controls
- Class 3 General Controls and Pre-Market Approval
Federal food and cosmetics law defines a medical device as an instrument, apparatus, equipment, machine, including any component, part and accessory.
These include;
- It is defined in the national formulary and either the U.S. pharmacopoeia or any supplement thereto.
- It is intended for use in humans or animals in the diagnosis of disease or in the treatment, mitigation, cure or prevention of disease or other conditions.
- It is intended to affect the structure or any process of the human or animal body such that it cannot achieve its primary intended purposes by chemical means in or on the human or animal body and is not dependent on being metabolized for the achievement of those primary intended purposes.
Important Links
Guidance Documents
http://www.fda.gov/cder/guidance/index.htm
Current Good Manufacturing Practice – cGMP Regulations
http://www.fda.gov/cder/dmpq/
FDA Approved Medicines (Search Engine)
http://www.fda.gov/cder/ob/default.htm
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.html
Coloring matters FDA
http://www.cfsan.fda.gov/~dms/opa-col2.html
Product Safety and Recalls
http://www.fda.gov/opacom/7alerts.html
FDA Müfettişleri Denetim Kılavuzları
http://www.fda.gov/ora/inspect_ref/igs/iglist.html
Guidances 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
Consumer Drug Information
http://www.fda.gov/cder/drug/default.htm#Consumer Drug Information