Overview of FDA Certification
Food and Drug Administration (FDA) established in 1906 is a government agency under the passage of the Federal Food and Drugs Act. It is the oldest comprehensive agency for consumer protection. The FDA Certification is mandatory for placing the products in the USA.
It is an agency which is part of the United States Department of Health and Human Services. This major responsibility of FDA is protecting and managing public health and related authorities by assuring the safety and security of human and biologically generated product. The FDA regulates products including biological products, medical services, cosmetics, prescription drugs and non-prescription drugs, veterinary drugs, tobacco and other radiation emitting products.
FDA issues form 483 for FDA Certification of the products after the inspection by an official of FDA. As per FDA guidelines, the food and drug plants in India should adhere to Current Good Manufacturing Practices (CGMP). FDA helps to ensure the safety, quality, and effectiveness of medical and food products produced in India for export to the United States.
What are the Type of Product for Obtaining FDA Certification?
FDA Certification depends on the type of product one is marketing in the United States. All kinds of products do not require the Certification of FDA. Below are the details of what products need FDA Certification.
- FDA Certification for Food
The food products do not require FDA Certification, but the food facilities are required to get registered with the FDA. The product, before being distributed in the United States, does not require any kind of certification from the FDA.
The FDA officials visit and check the food and pharma plants facilities in India. The official checks the compliances of the plants with the prescribed rules by the FDA.
- FDA Certification for Drug
The FDA check whether the drug conforms to the Over-the-counter (OTC) monograph or not. Drug products should be safe and effective. The OTC monograph establishes such conditions under which the drug products will be safe and effective for consumption. (OTC) monograph.
On the other hand, the new drug if it does not comply with the OTC monograph, the drug will require Certification from FDA. The drug manufacturers conduct some lab, human, animal testing and then submit the data to FDA. FDA will review the data provided and may give FDA certification to the product.
- FDA Certification for Cosmetics
The cosmetic products and their ingredients (other than Colour Additives) do not require FDA certification before marketing. The cosmetics companies do not require to get registered with the FDA, but the cosmetics products should be safe for use by consumers.
There are certain claims in cosmetic labelling, which may cause the FDA to regulate the cosmetic product as a drug product and in some cases, this may cause the cosmetic product to get approval certificate from FDA.
- FDA Certification for Color Additives
The colour additives used in food, drug, some medical devices and cosmetics require FDA Certification. There are certain high-risk colours which require colour batch certification from FDA. The use of colour additives can only be done within the compliances approved by FDA. The harmful colour additives are restricted under the FDA.
- FDA Certification for Medical Devices
The Medical Devices are placed into three risk-based categories by FDA. The categories are as follows: Class I, Class II, Class III. The Class III category medical devices are the highest-risk prone devices. These Class III devices only require Certification from FDA. The manufacturers of Class III medical devices should assure the FDA that these Class III devices are safe and effective for use.
1. Class I
Medical Devices pose minimal risk to the user. They include devices like elastic bandages, face masks, and tongue depressors. 47% of medical devices are categorized as Class I devices, and most of them (95%) are exempt from regulatory processes. This means most products in this class do not have to undergo any premarket process with the FDA.
2. Class II
Medical Devices pose a medium risk. This category represents 43% of all devices and includes a wide variety of devices from motorized wheelchairs to some pregnancy test kits to the Apple Watch ECG app. Some Class II devices are exempt from regulatory processes, but most must at least submit a 510(k), or premarket notification.
3. Class III
Medical devices pose the most risk to a patient. Only 10% of devices fall into this category. These are devices that are implanted into the body, life sustaining, or otherwise present an unreasonable risk. Class III devices include things like pacemakers, breast implants, and replacement heart valves. These devices must submit an application for Premarket Approval (PMA).
The manufacturers of Medical devices should register with FDA, and a detailed list of their Devices should be provided to FDA. The Registering and Listing with FDS does not indicate the FDA Certification of manufacturers and Devices.
What are the Benefits of FDA Certification?
- Impact within the Industry
FDA necessities are rigorous, and a product frequently takes a long time, a sequence of iterations and testing to get a ultimate FDA approval, but once you get it, this product will offer a major impact in the direction of the benefit of the consumer as it will be available for purchase, thus enhancing the lives, conditions, and health of your target market.
- In-Demand Product
Products that have FDA-approval rapidly move up the position in terms of demand. Consumers recognize it has been tested, and it's secure to use. Consequently, the demand for your product will boost up. Having the FDA's seal of approval is habitually a matter of a need, relatively than a nice object to have.
- Access to Worldwide Markets
FDA approval for your product also means you get a Certificate of Foreign Government (CFG). With this, you can essentially open up your deals points to initiate selling to countries like Japan, Brazil, Australia, & China. This displays other countries that your product has been FDA approved, and it can be marketed & exported from the United states of America.
- Increase Credibility
FDA is known globally, and it has acquired its own brand status. FDA has a unwavering principle and a long list of strategy to help a company achieve and get FDA approval. If your product gets the FDA approval that means it has been through meticulous product quality testing & various enhancement practices before being submitted to the FDA for evaluation.
- Expand Your Company's Expertise
Once you achieve FDA approval, it will make it a lot easier for your company to expand into other areas of business. Once your product has achieved FDA status, the next thing you'll need to do is continuously update, upgrade, and enhance your product, which can also mean moving into other industries.
- Enhanced Idea to Advance the Product
It’s about having more understanding of building a quality product right from the creation, design, testing, & production. Fundamentally, every single step of the way, it's all about exhibiting safety & efficacy concerns.
- Creates Lines for Funding
The good thing about FDA approval is you get to have to easier access to funding. FDA clearance displays that the product manufacturer is a stern and approved manufacturer. Big companies are for all time on the lookout for smaller companies in requirement of funding to add to their collection of products.
- Acknowledged in Medical Networks
A food or medical product will only be entertained by medical facilities and hospitals only if it has an FDA clearance. Without it, you can’t even sell your products in pharmacies. When building your product, you're bound to be working with medical facilities to do clinical trials, pilot testing, or usability devices. This is a great way to increase and expand your network.
What are the Documents Required for FDA Certification?
- Bill of Lading
- Airway Bill
- Purchase Order
Commodity Specific Documentation
- Packing List
- Growers List
- Labelling Copies
- Documentation stating the identity of the actual owner of the product
- The statement of the intended use or end use of the product
- Any other document as requested.
What is the Procedure for Obtaining FDA Certification?
FDA has the authority to inspect the facilities of foreign countries which supply food and drug products to the United States. The food and drug plants established in India that export products to the United States should adhere to the FDA guidelines of Current Good Manufacturing Practices (CGMP). The process of FDA Certification is as follows:-
- FDA officials visit the food and drug plants in foreign countries.
- The official of FDA then issues the Form 483 to the manufactures after the completion of the inspection.
1. The officials if find some deviations from FDA guidelines, it should be in Form 483.
2. Form 430 will specify the areas in which there is a variation from regulatory expectations.
3. The variations are then presented and are discussed with the management of the manufacturing company.
- The FDA also issues an EIR (Establishment Inspection Report). The EIR specifies whether an action should be taken or not. The procedure follows in the said pattern:-
• Pre-Clinical Testing
• Investigation New Application
• FDA Review
- The response to Form 438 should be submitted to FDA within 15 working days. The response should be detailed with proper reasons for the shortcomings. The new action plan to overcome the shortcomings should also be included in the response.
- After the response to Form 438 is submitted, a warning letter can be issued by FDA officials. The warning letter is issued if the officials of the FDA are not convinced with the response of Form 438.
- The response to the warning letter should be satisfactory and should be given within 15 working days. An unsatisfactory response may lead to cancellation of manufacturing license, withholding of product approval and import alert for products.
- After the FDA officials are satisfied the approval for import of drug is given by the FDA.
Sometimes, the FDA officials if finds that some observations while inspecting the food and drug plant are of severe nature, the FDA may directly issue a warning letter even without issuing Form 438.
What are the Additional Regulatory Organizations?
- CDRH – The Center for Devices and Radiological Health
The (CDRH) Center for Devices and Radiological Health is a regulatory bureau within the U.S. (FDA) of the Department of Health & Human Services. They have the accountability for implementing & enforcing the laws & regulations which apply to radiation-producing electronic products and medical devices that consist of lasers and light devices.
- IEC – The International Electro technical Commission
The IEC (International Electro technical Commission) is an international standards organization that prepares and publishes international standards for all electrical, electronic and related technologies – collectively known as “electrotechnology”.
- ANSI – The American National Standards Institute
The (ANSI) American National Standards Institute oversees the creation and dissemination of business norms & standards in the United States. ANSI is a private & nonprofit organization that does not expand standards itself, but oversee the formation of voluntary standards for a diversity of manufacturing processes, systems, products, services, & personnel in nearly every U.S. business sector. It also plants to ensure that U.S. principles are consistent with international principles enabling U.S. products to be sold & used abroad.
CorpBiz Procedure for FDA Certification
Kindly utilize the steps given above to integrate legally and securely a FDA Certification and get the benefits in the form of better-quality sales and satisfied clients. Our CorpBiz experts will be at your disposal for assisting you with guidance concerning FDA Certification and its compliance for the smooth functioning of your business in India. CorpBiz professionals will assist you in planning seamlessly at the least cost, confirming the successful conclusion of the process.
It is advisable that an attorney with “FDA experience” must be appointed to overwhelm many of the potential pitfalls that creep around within FDA Certification and to understand the requirement in detail. The elementary information would be mandatory from your end to start the process. The Attorney will begin working on your request once all the information is provided, and the payment is received.
CorpBiz is one of the platforms which coordinate to fulfil all your legal and financial requirements and connect you to consistent professionals. Our enthusiastic team of experts attempt to deliver risk-based assessments focusing on the health and well-being of the global population while minimizing the regulatory risk for our clients.
Our professionals have years of knowledge and experience as industry experts responsible for International Quality System Regulation, Inspections of Pharmaceutical and Medical Device Manufacturers, Biomedical Monitoring (BIMO), Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) audits.
Our clients can also track at all times the progress on our platform. If you have any questions about the FDA Certification process, our experienced representatives are just a phone call away. CorpBiz will ensure that your communication with professionals is charming and seamless.
- Purchase a Plan for Expert Assistance
- Add Queries Regarding FDA Certification
- Provide Documents to Corpbiz Expert
- Prepare Application for FDA Certification + Complete all Admissibility Criteria for Preliminary Screening
- Complete Procedural Actions
- FDA Certification at your Door Step!
Frequently Asked Questions
Form 483 is issued when the FDA officials at the conclusion of inspection observe some conditions which are in violation of FDA guidelines. FDA officials are required to mention all the observations in Form 483 clearly, specifically and significantly.
Form 483 of FDA notifies the management of the company about the objectionable conditions. After the conclusion of the inspection, Form 438 is presented and discussed with the senior management of the company. The management of the company is encouraged to respond to Form 438 in writing. The Form should include the correct action plan. The implementation of the action plan should be done expeditiously.
After the inspection, Form 438 is discussed with the management of the company. The observation of FDA officials in Form 438 is read and discussed for a complete understanding of what observations are and what they mean.
All the colour additives need prior FDA approval before being used in drugs, food or cosmetics. The Colour Certification of FDA is given for batches of colour which are manufactured for use on/in human beings and animals. At designated facilities, the thorough analysis of colour batches is done, and the FDA issues the FDA Colour Certificate.
The validity period of the Certification of FDA is one year from the date of the initial issue of the certificate. The validity period of FDA Certification can be increased based on a request from the company.
A delay in processing the entry of the food or drug products by FDA will be caused in case there is a failure in providing the entry documentation.
To sell and distribute tobacco product, the manufacturers should receive a written order from the FDA. The written order from the FDA does not indicate that the tobacco product is safe or approved by the FDA. The marketing order means that the manufacturer has complied with all requirements to bring the product in the market.
The Local FDA office at the entry of port should be contacted if there are any questions regarding the submission of documents.
The entry documents can be provided to the FDA in the following ways:
- The documents can be uploaded into ITACS (Import Trade Auxiliary Communication System). The documents can be uploaded by the customs broker, importer, or any other responsible party; or
- Find the contact page of import office and look for local import division postal address, email address and/or fax number for the submission of documents.