The U.S. FDA Certification guarantees that products being brought into the United States by the holder of the FDA certificate are deemed safe for consumption. It also confirms that these products comply with the FDA regulations set by the regulatory authorities. This means that anyone involved in manufacturing, processing, packaging, or repackaging of food, drugs, cosmetics, medical devices, etc., must obtain FDA certification to sell these products in the US and some other countries. Lets know about the process to get US FDA Certification Approval in India online.
Which products need US FDA Certification Approval?
| Product Type | FDA Certification Requirement | Additional Information |
| Food Products | Not required for individual products, but food facilities must register with FDA. | FDA officials may visit and inspect facilities for compliance. |
| Drug Products | Depends on adherence to the Over-the-counter (OTC) monograph for safety and effectiveness. New drugs may require FDA Certification. | Manufacturers conduct tests and submit data to the FDA for review. |
| Cosmetic Products |
FDA Registration along with FEI number is mandatory Furthermore, product listing of each product is also required. |
Some claims may lead to FDA regulation or certification. |
| Color Additives | Required for color additives used in food, drugs, medical devices, and cosmetics. Compliance with FDA standards is necessary. | High-risk colors may require batch FDA certification approval. Harmful additives are restricted. |
| Medical Devices | Facility Registration along with FEI number is mandatory. Furthermore, product listing of each product is also required. | Medical Devices are classified in 3 Classes. Class I, II, or III – based on their risks
Class I & II required Premarket Notification [510k] However, class III medical devices require Pre Market Approval [PMA]. |
Why is it important to get US FDA Certification?
Obtaining the US FDA certification is crucial for Indian businesses looking to enter the U.S. market with their food and drug products. It not only ensures compliance with standards but also enhances the credibility and quality of exported goods. Furthermore, there are several benefits of US FDA Certification to businesses.
Benefits of US FDA Certification
Customers’ Confidence
Obtaining U.S. FDA Certification boosts customer trust in product safety and quality, enhancing satisfaction and confidence.
Enhancement of Product Goodwill
US FDA Certification signifies rigorous validation, elevating product reputation and driving increased demand.
Expansion into Global Markets
US FDA(Food and Drug Administration) Certification opens doors to international markets, facilitating business growth and expansion into countries beyond the United States.
Attraction of Multiple Investments
The credibility of the U.S. FDA Certification attracts diverse investments, fueling further business development and innovation.
Stimulating Business Sector Development
U.S. FDA Certification encourages industry growth and innovation, fostering development within related sectors.
Enhancement of Product Efficiency
Certified products undergo regular checks and improvements, ensuring ongoing efficiency and market competitiveness.
Formation of Extensive Market Networks
U.S. FDA Certification establishes product networks, attracting small businesses and entities to engage, expanding market reach.
Streamlined Online Procedure
The online process for the U.S. FDA Certification offers convenience, though professional guidance is recommended due to formalities and documentation complexity.
Stepwise Process to get US FDA Certification Approval in India Online
Filling out the Form
You need to complete an online form called FURLS(FDA’s Unified Registration and Listing System). It asks for important details about your business, its owner, products, and a U.S. agent.
Inspection
After you submit the form and documents, authorities will check everything. They might even visit your business to make sure everything is okay.
Form 483
If there are any issues during the inspection, they’ll be listed in Form 483, which they’ll give to you. You have to respond within 15 days, explaining what went wrong and how you’ll fix it.
EIR Report
Sometimes, they’ll give you an Establishment Inspection Report. It tells you if there are any problems that need fixing, like testing or FDA reviews.
Warning Letter
If they’re not happy with your response to Form 483, they might send you a warning letter. You have to reply to this within 15 days, making sure they’re satisfied.
Certification
If they’re satisfied with everything, you’ll get a U.S. FDA Certification. But if they’re not happy, they might cancel your application. Sometimes they might even skip the warning and send it straightaway.
If you feel stressed about the process and want to save your time, money and efforts, you can contact our FDA Certification experts at: 8881-069-069. E-StartupIndia’s experienced and professional US FDA Certification experts can clear all your doubts and also assist you in getting US FDA Certification approval quickly and without hassle.
Document Requirement for US FDA Certification Approval
-
- Airway Bill & Invoice Bill of Lading
- Order for Purchase
- Specific Documentation for Each Commodity
- List of Items to Consider
- List of Growers
- Labelling Copies
- Documentation proving the identity of the product’s true owner
- The declaration of the product’s intended or final usage
- Any other documents which FDA requests during the process.
Conclusion
In summary, getting US FDA Certification is vital for Indian businesses exporting to the US and beyond. It guarantees product safety, boosts customer trust, and opens doors to global markets. The certification process can be complex, but with careful attention to detail and proper documentation, companies can achieve US FDA Certification and unlock the benefits of credibility, expanded market reach, and customer confidence.
You should also know:
If you need any more assistance regarding the US FDA Certification or have any other doubts regarding US FDA Labelling Requirements, you can call our experts at: 8881-069-069 and get quick assistance.
Download E-Startup Mobile App and Never miss the latest updates narrating to your business.