Today’s guide explores everything you need to know about FDA.
So, if you have any question about FDA, you will find the answer right here.
Keep reading to learn more.
- What Is FDA?
- What Is The Main Purpose Of The FDA?
- What Products Are Subject To FDA?
- What Are FDA Entry Types?
- What Is The FDA Entry Process?
- What Does It Mean For A Product To Be FDA Approved?
- What Is The Importance Of FDA Approval In Shipping?
- Do I Need To Register With The FDA?
- What Products Do Not Need FDA Approval?
- How Does The FDA Classify Medical Products?
- What Is A Premarket Approval In Relation To FDA Regulations?
- When Is A Premarket Approval Required When Shipping FDA Regulated Products?
- What Is The Difference Between Premarket Approval And 510K Premarket Notification?
- How Long Does FDA Approval Take?
- What Is The Difference Between “FDA Registered” And “FDA Approved” And “FDA Cleared”?
- What Is An FDA Hold In Shipping?
- Why Would The FDA Hold A Shipment?
- How Long Can The FDA Hold A Package?
- What Happens When The FDA Holds A Shipment?
- How Do I Perform An FDA Hold Status Check?
- What Can I Do If My Package Is Held By The FDA?
- What Is The FDA Product Code?
- What Is The Process For Importing FDA Regulated Products?
- Can A Customs Broker Help With FDA Custom Clearance?
- What Is The Cost Of Importing FDA Regulated Products?
What Is FDA?
food and drug administration
We can define food and drug administration as an agent that oversees the process of production of different products that we use and consume in our day-to-day lives.
The food and drug administration monitors products such as cosmetic products, medical equipment, biological products, and food.
They also regulate products that present to be a hazard. That is an emission of radiation which is harmful to the consumer of the products.
What Is The Main Purpose Of The FDA?
Food and drug administration’s perform a wide role in regulating what products the end-user purchases and consumes.
The following are some of the benefits of food and drug administration:
- Facilitate advancing of public health by ensuring a speed up process during product innovation.
- FDA offers protection of the public consumer from products that emit radiation for instance-rays
- They also offer regulations on the amount of content on tobacco products
- They inspect all the cosmetic products and food to ensure proper labeling to prevent consumers from using the wrong product.
This will cause effects on the body.
- They also ensure that all medical devices, vaccines, and biological products that humans use are effective and safe for them.
What Products Are Subject To FDA?
The food and drug administration regulates consumer products to protect public health.
There are certain products that FDA highly regulates.
These products include:
- Medical products: such products include, first aid kits, surgical instruments among others. The food and drug administration inspects the standards of these products to prevent preventing under quality equipment.
This will pose a threat to public health.
- Human food: FDA regulates what consumers take in terms of food, for instance, excess intake of food additives will cause health issues to the consumer.
- Another case is the dietary supplements that cause an increase in weight when the consumer takes them.
- This will lead to accumulations of fats in the body which is dangerous to your health.
- Human drugs: regulates and inspects all drugs coming in from other countries.
This prevents an increase of counterfeit drugs which will cause a serious problem to the consumer
- Cosmetic products: inspects these products to evaluate if the ingredients used meets the threshold.
As a result, preventing any side effects on the consumer’s body and face.
These products include face creams, shampoo, artificial eyelashes among others.
- Radiation emitting electronic products such as microwaves, X-ray equipment, LEDs, Laser printers pose a health crisis to the public. users.
The FDA ensures low emitting devices are available with guidelines of their usage.
- Tobacco products: FDA ensures the percentage of tobacco in cigarettes, e-cigarettes, and smokeless tobacco meets the specifications given threshold.
- High nicotine in these products causes health issues among the users such as lung cancer due to the high concentration of the substance.
- Biological products, vaccines, and blood: FDA ensures accurate examination of these products before the consumer receives them.
For instance, you should examine the blood for the presence of additional elements, also the body organs should be a match and to the receiver to avoid health crises.
What Are FDA Entry Types?
FDA entry types
Entry type refers to all types of goods that a country allows in via the help of regulatory bodies like the FDA and CPB.
FDA entry uses an Automated broker interface program to achieve the entries electronically.
Food and drug administration process different types of entries. These FDA entries include
Consumption Entry: allows importing goods into the US without issuing requests for the goods and the time.
You can either use these goods for commercial, personal, or business purposes.
With consumption entry, different individuals are responsible for this entry.
- The owner
- Custom brokers
We can further classify consumption entry into:
- Informal entry
- Formal entry
In cases of warehouse and import for export FDA entries, they help in removing goods that are entering us.
Other FDA entries include;
- Immediate transportation
- Transportation and exportation
- Temporary importation under bond
- Foreign trade zone
What Is The FDA Entry Process?
The food and Drug Administration entry process involves the steps that custom brokers follow while shipping the products into the country.
These processes include:
If these products are FDA regulated, the customs broker submits custom entry documents to the FDA.
In other cases, the customs broker will submit prior notice to the FDA in case they need more time.
Usually, the customs broker should submit this notice two hours before the arrival of the shipment.
This gives the FDA more time to pre-examine all entries and decide on whether the shipment will cross or needs more examination.
We recommend custom brokers to ensure that products enter the country during the day to allow reviewing at the arrival port.
In case the FDA issues reviews of the products, custom brokers will send a notification to the owner to hold goods longer.
This allows the customs broker to clear any pending issues with FDA to prevent additional charges or refusal of goods entry.
What Does It Mean For A Product To Be FDA Approved?
The main responsibility of food and drug administration is to carry out tests, examinations, reviews and provide approval of products for human consumption.
These products range from medical devices, food, cosmetics, tobacco products, and biological products.
Therefore, for FDA to approve these products they must meet a certain threshold which means they do not pose any danger to the consumers.
Hence, protecting the consumers’ health.
What Is The Importance Of FDA Approval In Shipping?
Food and Drug Administration is important in shipping in the following ways:
- Counterchecks all paper documents to ensure that the shipment does not pose a danger to public health.
- They implement final rules on FDA regulated products such as biological products, food, and medical devices.
- It reduces the holding of goods at the port when the owner provides relevant documents.
- FDA approval also fastens the process of shipping.
This means if the products qualify and adhere to the law FDA will release them immediately.
Do I Need To Register With The FDA?
Yes. To allow easy importation of these products it is important to register with food and drug administration.
Normally, when importing these products into us, you need to register because each product has specific registration variations.
Below are some examples of products and how to register them;
Cosmetic products you should check in with voluntary cosmetic registration program which works as FDA post market reporting system.
This body provides approvals of cosmetic products for manufacturers and distributors.
Tobacco products: if your business in the production, selling of this product you should register with food and drug administration.
You should include sources and types of materials you are using to manufacture these products.
What Products Do Not Need FDA Approval?
Products that do not need FDA approval
In some cases, the food and drug administration does not approve all the products the importers are shipping into the country.
Some of these products pose health risks to the consumer and therefore the FDA will take a longer time to review this product.
These products that do not require food and drug administration approval include;
We all know what danger tobacco products pose to human health.
Therefore, the FDA standards examining medical products can not apply to tobacco products.
The law requires you to obtain a written food and drug administration order to allow the production and selling of tobacco products.
The dangers of tobacco products will always bring setbacks to the manufacturer while approaching the market.
As a result, the manufacturer can use the following ways to penetrate the market:
- Premarket tobacco applications
- Substantial equivalence applications
- Exemptions from equivalence applications.
- Compounded drugs
They are a result of a combination of different elements by the pharmacies or doctors to produce medication that best suits patient needs.
FDA approved medicines contain elements that may cause an allergic reaction to different patients when they take these medicines.
Therefore, the Food and Drug Administration does not approve these compound drugs due to the health issue they pose to patients.
As the manufacturer of these products, it’s your responsibility to accurately label and give a description of their usage to consumers.
The food and drug administration does not need to approve these products before reaching the market.
This is because manufacturers will always find ways of penetrating these products to the market.
The marketing of infant formula allows consumers to sample these products. Thereafter the FDA will evaluate consumer feedback on the infant formula
If this product poses a threat to public health, the FDA declines to approve this product.
In cases of a new brand of infant formula, the manufacturer should provide samples and ingredients for examination to the FDA authorities.
Normally, we use medical foods to care for the needs of the patients who require specific nutrients foods.
For instance, patients who are diabetic require insulin to low the sugars in the body
Additionally, the FDA does not require the manufacturer to label the products but rather provides accurate information.
How Does The FDA Classify Medical Products?
We can classify medical products into three classes.
It is important to acquire relevant information that helps you understand how these classes work. This normally occurs before submission to the food and drug administration.
This classes results from 16 medical specialists.
These classes include:
This class contains general controls providing exemption and in some cases no exemptions
We do not associate this device with high risks of danger
Examples of class1 medical devices are, face masks, bandages,
Class 1 with exemption devices requires the 510k for marketing purposes
This class contains the general controls and special controls providing exemption or no exemptions.
This class also requires 510k for a device with an exemption.
Contains general controls and pre-market approval
These devices cause high risks of danger to the patients.
For example; an oxygen support machine
What Is A Premarket Approval In Relation To FDA Regulations?
Premarket approval normally occurs when the manufacturer clears with the FDA.
This normally occurs when the manufacturer presents a new product.
The FDA will approve the product to penetrate the market and later will review the consumer feedback.
This allows them to determine if the product will pose danger to the consumers, before giving marketing approval.
When Is A Premarket Approval Required When Shipping FDA Regulated Products?
You will require a premarket approval while shipping products considered to pose a great danger when consumer user them.
For instance, if the owner is shipping medical devices that fall under class 3. They will require a premarket approval because they pose a great danger to patients.
What Is The Difference Between Premarket Approval And 510K Premarket Notification?
Both premarket approval and 510k premarket notification have distinguishing functions thus making them different.
Below are some of the main differences:
Premarket approval applies for totally new products in the market such as the class 3 medical devices.
Timeframe for premarket approval is strictly 6 months.
With premarket approval, the food and drug administration conduct thorough research to determining ease penetration of product to market.
This normally occurs the product poses great danger.
With remarket approval, the food and drug administration should approve or decline the product.
Premarket approval entails a lot of paper documentation that provides the plan for the establishment of these products.
On the other hand,
510k premarket notification applies when the manufacturer produces a similar product to that existing in the market.
The timeframe of submitting the 510k premarket notification is an average of 90 days which makes it faster and affordable.
Allows illustrations of the products to prove distinct features from the existing one
Also, 510k premarket notification does not require showcasing of all information.
There is an exemption if the manufacturer alters the products to perform the same functionalities.
Submitting 510k only guarantees the clearance process and therefore you cannot advertise it as food and drug administration approval.
How Long Does FDA Approval Take?
Food and Drug Administration requires a certain timeframe for the complete approval process. This timeframe depends on the following;
Submission of the 510k applications
Submission of premarket approval
If you register individually.
Considering these factors FDA approval will take between 5 working days to 120 (equivalent to 8 months).
What Is The Difference Between ‘’FDA Registered’’ And ‘’FDA Approved’’ And ‘’FDA Cleared’’?
There are unique features that make each of them different features apply while evaluating what regulations govern them.
These differences include;
FDA approved implies a complete examination and review of products to ensure they are safe and effective for human consumption.
This means the products should not pose any health risks to the consumers.
FDA cleared applies where the manufacturer presents to the FDA a product that is like that existing in the market.
The FDA request for demonstrations to prove the product achieves the FDA regulations i.e., safety and effectiveness.
After a successful demonstration, the FDA will clear this product for marketing. This process is what we term as FDA cleared.
FDA requires the manufacturers to register with them before releasing their products to the markets.
Registration of the products allows the FDA to be aware of all activities you undertake to produce the products.
The main importance of registration is to help deal with any arising issues from malfunctioning devices.
What Is An FDA Hold In Shipping?
We can refer to food and drug administration as a form of custom hold at the custom clearance offices.
FDA hold occurs mainly when the FDA finds the need to hold products for further detailed examination.
The FDA will request more documentation to prove the usage of the products.
This decision is a result of goods not meeting the FDA threshold.
Therefore, the FDA will hold these goods for as long as the details are unclear.
Why Would The FDA Hold A Shipment?
The key importance of the FDA is to evaluate and examine products for the safety of the consumers.
If this product does not meet these standards, FDA will hold these goods and send a holding notification to the relevant individuals.
The FDA holds this shipment if the owner refuses to provide proof that the product complies with the law.
Failure to provide a plan to bring the product into compliance
Failure to accept that the products violate the law.
How Long Can The FDA Hold A Package?
On normal occasions, FDA will hold this package for a period of 1 to 2 days, but under special circumstances, it can take even months.
The earlier the owner provides the information that the FDA request the faster they will release these packages.
Delays as a result owner withholding information will lead to a long period of holding.
What Happens When The FDA Holds A Shipment?
Normally, FDA holds products if they suspect that they need further inspection or provision of unclear information.
In case the FDA holds they will send a notification to the customs broker who has an obligation of notifying the owner.
The FDA will request additional information about the product
They might as well pick samples for lab testing
All these procedures help to determine if the products meet the US laws and regulations.
How Do I Perform An FDA Hold Status Check?
This status check is achievable by;
You can use the custom broker to follow up on the holding process
You can also contact the FDA via their platform.
This will require you to fill in your details in a form.
This form includes entry number, CPB, and FDA number.
THE FDA will communicate back to you.
What Can I Do If My Package Is Held By The FDA?
Normally if the food and drug administration hold the package, you should consider the following two options:
- Submit a request to allow you to make changes to the products to clear the violation issues.
- You can submit proof of the product’s information to the FDA to clear the violation. Submission of proof further allows the FDA to conduct a further examination.
What Is The FDA Product Code?
Food and Drug Administration product code provides a description of the products and what group they belong to.
FDA product code usually contains seven alphanumeric characters. It is made up of different elements such as;
- Product industry code
- Class code
- Subclass code
- Process indicator code
- Group code
What Is The Process For Importing FDA Regulated Products?
Importing products that under FDA regulations requires:
Involve custom brokers who act as third parties.
The ensure submission of relevant documents and make payments for all the entries.
The Customs broker will make an entry with Customs and Board Protection and later include an HTS.
The HTS consists of tags that assist food and drug administration which information is important and which is not.
The HTTUS code determines if the product meets the FDA standards. If it’s the case submission of all documents takes place.
Can A Customs Broker Help With FDA Custom Clearance?
Custom brokers act as agents between the buyer and the seller.
Thus, preventing direct involvement.
Customs brokers play a vital role in the customs clearance process.
Custom brokers help in the following ways;
They ensure that the goods you are importing adhere to FDA regulations
They determine a suitable harmonized tariff schedule which is a requirement by the customs and border protection.
Custom brokers provide you with FDA information and affirmation of compliance requirements.
During the entry of goods, they will always acquire a bond for you which help in the payment of the products.
They prepare and provide all the documentation to the food and drug administration.
They use Automated Broker Interface to transmit all information to FDA and back to the owner.
A customs broker can file a notice before.
They also provide answers to queries regarding FDA custom clearance.
What Is The Cost Of Importing FDA Regulated Products?
It is important to evaluate all possible cost options while importing FDA regulated products. Normally, these costs vary differently depending on the following factors:
The type of product you are importing into the country.
This means every product type you import will have costs differently normally due to sizes.
How much are the products worth?
This implies if the products constitute a high amount of money.
The cost charges will increase.
We can also determine the cost by the longevity period that the owner has been in business.
This means if the owner has been in business for long, they will pay less.
For start-up businesses, the costs are high which poses a challenge to the business owner.
Costs will vary from bond charges, shipping charges, and duties.
And it’s the responsibility of the business owner starting up to be aware and prepare for these costs.
In case you have problems with product quality inspection, BanSar is here to help.