Overview of US FDA Certification in India

If anyone wants to export the items such as Food, Drugs, Cosmetics, Color Additives, Medical Devices, Supplement, Even PPE Kit to the U.S.A, they must obtain US FDA Certification. The US FDA Certifications main purpose is to protect and manage public health in the United State of America. The US FDA also focuses on guaranteeing the security and protection of the biologically generated product.

The US FDA(Food and Drug Administration) was established in 1906 and is currently the government agency working under the Federal Food and Drugs Act. The FDA is one of the oldest agencies in the world for consumer protection. Thus, US FDA Certification becomes a valuable asset as well as a mandatory milestone to start expansion of your business in the U.S.A.

Following an examination by an FDA official, the FDA provides Form 483 for FDA Certification of the items. According to FDA rules, food and pharmaceuticals manufacturing facilities in India must follow Current Good Manufacturing Practices (CGMP).

The list of products that US FDA Regulates are biological products, medical services, cosmetics, prescription drugs and non-prescription drugs, veterinary drugs, tobacco and several other products such as radiation emitting machines etc.

What is the US FDA Certification?

US FDA Certification simply is a certificate to indicate that your product is safe and effective for use. It also indicates that the items being exported to the U.S.A are following the CGMP(Current Goods Manufacturing Practices) as set by the FDA Guidelines. All the businesses involved in the processing of food, drugs, medical devices, cosmetics must obtain US FDA Certification in India. If you fail in getting US FDA Certification, you can not enter into the U.S. Market.

The US FDA Certificate includes detailed and valuable information about the products standards as well as its quality or regulation. It also includes the name of the recipient company.

Benefits of US FDA Certification in India

The US FDA Certification is a popular certification across the globe. Therefore it offers multiple advantages such as-

#1. US FDA Certification instills the trust in the heart of your customer. It isn't easy to get US FDA Certification in India. There are rigorous procedures, including site verification, involving US full time agents plus lengthy document preparation steps. Thus, if you get it, the customers start believing in your products quality and efficiency.

#2. The FDA Certified products become popular easily. Consumers realise that it has been well tested and is safe to use. As a result, demand for your goods will increase. Furthermore, the information about your products start spreading through word of mouth after receiving US FDA Certification.

#3. US FDA Certification isn't only valid for the USA only. The certification also provides business opportunities in other countries such as Japan, U.K., China, Australia etc. One can also export the products manufactured in the USA having US FDA Certification to other parts of the world.

#4. It will be much easier for your organisation to develop into other sectors of business after you have received US FDA Certification in India. You can use similar kinds of procedures used while obtaining US FDA Certification to develop the other items.

#5. Funds and Investment is an important part of business to keep it running smoothly. Getting a US FDA Certification in India indicates your products are worthy of investment. Hence, you can raise investment from multiple sources.

#6. Mostly US FDA Certifications are related to Medicinal Equipment and Products. Getting a US FDA Certification in India ensures your expansion in medical networks and also doctors and other hospital staff mostly prefer using only these products.

What are the US FDA Regulated Products which requires US FDA Certification in India

It is important to note that not every product you want to export in the U.S.A. requires US FDA Certification in India. However, there are several products in which without having US FDA Certification, you can not export them. The list of FDA Regulated Products which Requires US FDA Certification in India is mentioned below.

#1. Food Products
Food Items do not require FDA Certification. However, every Food Facility or FBO that stores, prepares, packages, serves, vends, or otherwise provides food for human consumption is required to have US FDA Certification in India. The US FDA Officials also visit the business establishments to evaluate the food and pharmaceutical manufacturing plants. As a result, they ensure the business complies with FDA Rules, Regulations and Standards. This also includes businesses dealing with Animal Food Products.

#2. Medical Devices and Equipment
Medical Devices and Equipment are an important product for every nation. They directly impact the health of the user. Therefore, the US FDA has decided to classify the medical devices and equipment that need US FDA Certification in India. These are described below.

- Class 1 ( Devices such as Elastic Bandages, Tongue Depressors, Face Masks etc.)

- Class 2 ( Devices such as Motor Wheelchairs, Pregnancy Test Kits, Apple Watch etc.)

- Class 3 (Devices such as pacemakers, breast implants, Heart Valve replacements etc.)

Here, Medical device makers should register with the FDA and supply FDA with a full list of their products. The FDA does not certify firms or devices based on their registration and listing with FDA. Thus, the organization needs to get US FDA Certification for the applicable products under all these three classes.

Important Note:- Anyone who wants to market a Class I, II, or III device intended for human use in the United States must submit a 510(k) to FDA unless the device is exempt from the 510(k) requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and does not exceed the limitations of exemptions in.9 of the device classification regulation chapters.

#3. PPE Kit
PPE applies to protective gear, helmets, gloves, face shields, goggles, facemasks, and/or respirators, as well as other devices meant to keep the wearer safe from damage or the transmission of virus or ailment. In health-care environments such as hospitals, doctor's offices, and clinical labs, personal protective equipment (PPE) is routinely employed.

When worn correctly, personal protective equipment (PPE) functions as a barrier between infectious elements. Depending on the kind of PPE, the FDA's regulations and consensus criteria differ. Therefore, PPE Kit manufacturers need to obtain US FDA Certification in India. The FDA reviews PPE Kits in India so they can be legally sold in the United States.

#4. Supplements
Both completed dietary supplement products and dietary components are regulated by the FDA. Dietary supplements are regulated by the FDA under a distinct set of rules than "standard" foods and drugs. It is illegal for manufacturers and distributors of dietary supplements and dietary components to advertise adulterated or misbranded products. This implies that these companies are responsible for assessing the safety and labelling of their goods prior to marketing to ensure that they fulfil all DSHEA, FDA laws and achieve US FDA Certification. Furthermore, the US FDA can take strict action if a supplement is adulterated or uses misbranding .

#5. Drugs
The FDA works in collaboration with CDER(Center for Drug Evaluation and Research) to ensure only the safe and effective drugs reach US Citizens. Tens of millions of individuals in the United States rely on prescription and over-the-counter pharmaceuticals to maintain their health nowadays, with more than four billion drugs prescribed each year.

Too many individuals, however, are hospitalised unnecessarily, and some are killed as a result of hazardous pharmaceutical mistakes. Thus, the US FDA evaluates the drugs manufacturing organizations and makes it mandatory to obtain US FDA Certification for them.

#6. Cosmetics
Cosmetic goods and components, with the exception of colour additives, do not require FDA clearance before entering the market. However, there are rules and regulations that apply to cosmetics sold in the U.S.A by other nations. Therefore, US FDA Certification and US FDA prevents adulteration of cosmetic products.
As per the U.S. FDA Regulations, Cosmetics are defined as "items intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for washing, beautifying, enhancing attractiveness, or modifying the look" under the FD&C Act (sec. 201(i)). Skin moisturisers, fragrances, lipsticks, fingernail polishes, eye and face cosmetics, cleaning shampoos, permanent waves, hair colours, and deodorants, as well as any ingredient intended for use as a component of a cosmetic product, are all covered in this description. Thus, businesses outside the U.S dealing with cosmetics need to apply for US FDA Certification.

List of products not FDA Approved�

#1. US FDA does not approve Health care providers, including physician offices, or laboratories

#2. Compounded drugs are not FDA approved.

#3. The transplantation of vascularized human organ transplants, such as kidney, liver, heart, lung, or pancreas, is not subject to regulation by the FDA and is not FDA Approved.

#4. Tobacco products are not approved by the FDA.

#5. The FDA does not approve cosmetics except color additives. (other than coal-tar hair dyes)

#6. The FDA doesn't approve medical foods.

#7. Infant formulas are not required to obtain FDA approval prior to being marketed.

#8. Dietary supplements are not subject to FDA approval.

#9. The FDA does not provide approval for the food label, including the Nutrition Facts label.

#10. The FDA does not grant approval for structure-function claims on dietary supplements and other foods.

Misuse of FDA logo & Consequences

The FDA's logo is exclusively intended for official government purposes.

It should not be utilized in a manner that distorts the agency's image or implies endorsement by the FDA of any private organization, product, or service.

The FDA logo is exclusively intended for official use by the U.S. Food and Drug Administration (FDA), and it should not be used on materials from the private sector.

Using the logo in such a context can mistakenly imply FDA endorsement of a private organization, its activities, products, services, or personnel, which it does not do.

So, Unauthorized use of the FDA logo is against federal law and may result in civil and/or criminal liability.

Things to keep in mind while applying for US FDA Certification in India

Following are some of the most important aspects to keep in mind while applying for US FDA Certification in India.

To apply for US FDA Registration from India, you must ensure availability of a full time US agent in the USA to receive notices, other FDA communications and timely respond.

The firm requesting clearance for US FDA Certification to commercialise a medicine is responsible for conducting laboratory and animal experiments on the drug's safety and effectiveness, and then submitting the results to FDA for assessment by CDER doctors, statisticians, chemists, pharmacologists, and other scientists.

For items controlled by the Food and Drug Administration, domestic enterprises exporting goods from the United States are also frequently required to provide a US FDA Certification by their overseas clients or governments.

Domestic and international organizations that manufacture, repackage, or re-mark medical products in the United States must register with the FDA. Domestic and international pharmaceutical manufacturers, repackers, and re-labelers must also declare all of their financially supported medical products. This information allows the FDA to maintain a database of all drugs in use in the United States.

The Voluntary Cosmetic Registration Program (VCRP) is an FDA post-advertise disclosure framework for cosmetic item manufacturers, shippers, and dealers operating in the United States.

The FDA is in favour of electronic accommodations. FDA uses the FDA Unified Registration and Listing System(FURLS) to store such data electronically. Hence, you can get US FDA Certification in India online.

There are four major types of drug certification applications that can be applied to the US FDA. These are -

• 1. Investigational New Drug (IND)
• 2. New Drug Application (NDA)
• 3. Abbreviated New Drug Application (ANDA)
• 4. Biologic License Application (BLA).

Why is US FDA Certification in India important?

The US FDA Certification in India allows you to market and sell the products legally in the USA and other nations too.

The price you pay is quite less as compared to the benefits you avail for US FDA Certification.

US FDA Certification in India also aids in having a highly impactful trust of your products on Indian Consumers. As a result, your brand becomes the symbol of Credibility.

Whether you need more information on how to categorise your device or need US FDA Certification, you will definitely develop a relationship with FDA in order to get your product to market.

Documents Requirement for US FDA Certification in India

#1. Airway Bill & Invoice Bill of Lading

#2. Order for Purchase

#3. Specific Documentation for Each Commodity

#4. List of Items to Consider

#5. List of Growers

#6. Labelling Copies

#7. Documentation proving the identity of the product's true owner

#8. The declaration of the product's intended or final usage

#9. Any other documents that have been requested.

You can contact our business advisors at - 8881-069-069 for free and understand the Documents Requirement for US FDA Certification in detail.

How to get US FDA Certification in India?

E-startupIndia is a team of experienced professionals to assist you in getting US FDA Certification in India. Our team of experts can help you obtain US FDA Certification from beginning to end. From document preparation to final application approval, we are here to serve you with a variety of services so that your business can reach new heights globally.

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