US FDA Certification Services in India

Export your products to the USA with Aone Filing’s expert US FDA Certification services. Our professionals simplify compliance with US import regulations, ensuring hassle-free certification for food, drugs, cosmetics, medical devices, and more.

Overview of US FDA Certification

The US FDA (Food and Drug Administration), established in 1906, is a leading consumer protection agency ensuring the safety and efficacy of products like food, drugs, cosmetics, medical devices, supplements, and PPE kits. Exporters from India must obtain US FDA Certification to enter the US market, adhering to Current Good Manufacturing Practices (CGMP). The certification, including Form 483 issued after FDA inspection, is a critical step for global market expansion.

What is US FDA Certification?

US FDA Certification confirms that products meet safety and quality standards per FDA guidelines, ensuring compliance with CGMP for food, drugs, cosmetics, and medical devices. It’s mandatory for exporting these products to the USA, providing detailed information on product standards and quality.

Benefits of US FDA Certification

US FDA Regulated Products

• Food Products: Food facilities (preparation, packaging, storage) require certification, including animal food products.
• Medical Devices: Classified into Class 1 (e.g., bandages), Class 2 (e.g., wheelchairs), and Class 3 (e.g., pacemakers), requiring 510(k) submission unless exempt.
• PPE Kits: Protective gear like masks and gloves must meet FDA standards for healthcare use.
• Supplements: Regulated under DSHEA, ensuring safety and proper labeling.
• Drugs: Prescription and over-the-counter drugs require approval via CDER for safety and efficacy.
• Cosmetics: Must comply with FDA regulations to prevent adulteration, except for color additives.

Products Not FDA Approved

• Healthcare providers and laboratories.
• Compounded drugs.
• Vascularized human organ transplants (e.g., kidney, liver).
• Tobacco products.
• Cosmetics (except color additives).
• Medical foods and infant formulas.
• Dietary supplements and structure-function claims.
• Food labels, including Nutrition Facts.

Misuse of FDA Logo & Consequences

The FDA logo is for official use only and cannot be used to imply endorsement of private products or organizations. Unauthorized use violates federal law, potentially leading to civil or criminal liability.

Key Aspects for US FDA Certification

• Appoint a full-time US FDA Agent for communication and emergency contact.
• Conduct laboratory and animal tests for drug safety and efficacy, reviewed by CDER experts.
• Domestic and foreign manufacturers must register and list products with the FDA.
• Use the FDA Unified Registration and Listing System (FURLS) for electronic submissions.
• Types of drug applications: Investigational New Drug (IND), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Biologic License Application (BLA).

Importance of US FDA Certification in India

• Enables legal marketing and sales in the USA and other countries.
• Cost-effective compared to the benefits of market access and credibility.
• Builds trust among Indian consumers, enhancing brand reputation.
• Establishes a relationship with the FDA for smoother product approvals.

Importance of US FDA Agent

Foreign exporters must appoint a US FDA Agent (a US resident or entity with a physical presence) to act as a liaison with the FDA, handling communications and certifications. The agent must be accessible during business hours and cannot use a PO box as an address.

Documents Required for US FDA Certification

• Airway Bill & Invoice Bill of Lading.
• Purchase Order.
• Specific documentation for each commodity.
• List of items and growers.
• Labeling copies.
• Proof of product ownership.
• Declaration of product’s intended or final use.
• Any additional requested documents.

Contact our advisors at +91-9211963599 for detailed document requirements.

How to Get US FDA Certification

Aone Filing’s expert team guides you through the entire process, from document preparation to appointing a US FDA Agent and filing applications, ensuring compliance with FDA regulations for seamless certification.

Step-by-Step Timeline for US FDA Certification

1. Consultation with our experts to understand your export products.
2. Provide required documents and information.
3. Our team appoints a registered US FDA Agent and files the application.
4. Receive your US FDA Certification after successful verification by FDA officials.

Note: Verification time varies depending on FDA processes.

How Aone Filing Can Help

At Aone Filing, our team of Chartered Accountants, Lawyers, and Company Secretaries simplifies the US FDA Certification process. Since 2014, we’ve completed thousands of registrations, ensuring compliance with FDA standards. From document preparation to handling objections, we manage all legal formalities, allowing you to focus on your business growth. Contact us to skyrocket your exports with ease.

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