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Overview

FDA Certification

The NABL (National Accreditation Board for Testing and Calibration Laboratories) Certification is a recognition granted to testing and calibration laboratories for demonstrating competence in accordance with ISO/IEC 17025 standards. It is issued by NBL, an autonomous body under the Quality Council of India (QCI). This certification validates the technical competence, accuracy, and reliability of a laboratory’s testing and calibration procedures. FDA Certification is essential for laboratories to build trust, gain credibility, and ensure acceptance of their results nationally and internationally.

Importance

1. Legal Compliance : Ensures adherence to U.S. federal laws for product safety and efficacy.

2. Consumer Safety : Protects consumers by guaranteeing product quality and health standards.

3. Market Access : Enables businesses to sell regulated goods in the lucrative U.S. market.

4. Enhanced Credibility : Builds trust with consumers, distributors, and stakeholders.

5. Avoidance of Penalties : Prevents fines, bans, or recalls for non-compliant products.


Documents Required

For Indian Nationals


For Foreign Nationals



Features

Features & Benefits of FDA Certification

Product-Specific Regulations
Tailored requirements for food, drugs, cosmetics, and medical devices.
Prev Next
Manufacturing Standards
Ensures adherence to FDA Good Manufacturing Practices (GMP).
Prev Next
Facility Inspections
Includes inspections to verify compliance with FDA guidelines.
Prev Next
Global Recognition
Builds international trust in the product’s safety and quality.
Prev Next
Enhanced Market Access
Essential for exporting regulated goods to the U.S. market.
Prev Next

FDA Certification

Compliance with Labeling Standards
Ensures product labels meet U.S. regulatory guidelines.
Prev Next
Clinical and Lab Testing
Requires thorough product testing for pharmaceuticals and medical devices.
Prev Next
Ongoing Surveillance
Products are subject to periodic FDA audits and reviews.
Prev Next
Pre-Market Approval
Needed for high-risk products such as drugs and Class III medical devices.
Prev Next
Mandatory U.S. Agent Representation
Required for foreign manufacturers.
Prev Next


Comparison with CE Mark Certification

Feature FDA Certification ISO/IEC 17025 Certification
Purpose Compliance with U.S. standards Compliance with EU standards
Applicable Markets United States European Union
Focus Area Safety, efficacy, and GMP Safety, performance, and health
Mandatory for Entry Yes, for U.S. market Yes, for EU market
Labeling Requirements Stringent FDA labeling norms CE mark placement requirements


Frequently Asked Questions

Is FDA Certification mandatory for all products sold in the U.S.?

Yes, it is mandatory for regulated products such as food, drugs, cosmetics, and medical devices.

How long does the FDA approval process take?

The timeline varies based on the product category and complexity, ranging from 3 months to 2 years.

What is the cost of FDA Certification?

Costs depend on the product type, application fees, testing, and facility inspections.

Can Indian manufacturers apply for FDA Certification?

Yes, Indian manufacturers can apply by registering their facilities and appointing a U.S.-based agent.

Is FDA Certification recognized internationally?

Yes, it enhances global trust and facilitates market access in other regions.

What are the penalties for selling non-FDA-compliant products?

Penalties include fines, product recalls, bans, and potential legal action.

What is an FDA 510(k) application?

It is a pre-market submission required for Class II medical devices, demonstrating substantial equivalence to a legally marketed device.

Does FDA Certification apply to cosmetics?

Cosmetics do not require pre-market approval but must comply with FDA labeling and safety guidelines.

What are the FDA’s GMP requirements?

GMP includes practices for safe manufacturing, quality control, and documentation.

Can foreign companies sell FDA-approved products in the U.S.?

Yes, but they must register their facilities and appoint a U.S. agent.

FDA Certification

Overview

FDA Certification

The NABL (National Accreditation Board for Testing and Calibration Laboratories) Certification is a recognition granted to testing and calibration laboratories for demonstrating competence in accordance with ISO/IEC 17025 standards. It is issued by NBL, an autonomous body under the Quality Council of India (QCI). This certification validates the technical competence, accuracy, and reliability of a laboratory’s testing and calibration procedures. FDA Certification is essential for laboratories to build trust, gain credibility, and ensure acceptance of their results nationally and internationally.

Importance

1. Legal Compliance : Ensures adherence to U.S. federal laws for product safety and efficacy.

2. Consumer Safety : Protects consumers by guaranteeing product quality and health standards.

3. Market Access : Enables businesses to sell regulated goods in the lucrative U.S. market.

4. Enhanced Credibility : Builds trust with consumers, distributors, and stakeholders.

5. Avoidance of Penalties : Prevents fines, bans, or recalls for non-compliant products.


Documents Required

For Foreign Nationals


For Foreign Nationals



Features

Features & Benefits of FDA Certification

Product-Specific Regulations

Tailored requirements for food, drugs, cosmetics, and medical devices.

Manufacturing Standards

Ensures adherence to FDA Good Manufacturing Practices (GMP).

Facility Inspections

Includes inspections to verify compliance with FDA guidelines.

Global Recognition

Builds international trust in the product’s safety and quality.

Enhanced Market Access

Essential for exporting regulated goods to the U.S. market.

Compliance with Labeling Standards

Ensures product labels meet U.S. regulatory guidelines.

Clinical and Lab Testing

Requires thorough product testing for pharmaceuticals and medical devices.

Ongoing Surveillance

Products are subject to periodic FDA audits and reviews.

Pre-Market Approval

Needed for high-risk products such as drugs and Class III medical devices.

Mandatory U.S. Agent Representation

Required for foreign manufacturers.



Comparison with CE Mark Certification

Feature FDA Certification ISO/IEC 17025 Certification
Purpose Compliance with U.S. standards Compliance with EU standards
Applicable Markets United States European Union
Focus Area Safety, efficacy, and GMP Safety, performance, and health
Mandatory for Entry Yes, for U.S. market Yes, for EU market
Labeling Requirements Stringent FDA labeling norms CE mark placement requirements


Frequently Asked Questions

Is FDA Certification mandatory for all products sold in the U.S.?

Yes, it is mandatory for regulated products such as food, drugs, cosmetics, and medical devices.

How long does the FDA approval process take?

The timeline varies based on the product category and complexity, ranging from 3 months to 2 years.

What is the cost of FDA Certification?

Costs depend on the product type, application fees, testing, and facility inspections.

Can Indian manufacturers apply for FDA Certification?

Yes, Indian manufacturers can apply by registering their facilities and appointing a U.S.-based agent.

Is FDA Certification recognized internationally?

Yes, it enhances global trust and facilitates market access in other regions.

What are the penalties for selling non-FDA-compliant products?

Penalties include fines, product recalls, bans, and potential legal action.

What is an FDA 510(k) application?

It is a pre-market submission required for Class II medical devices, demonstrating substantial equivalence to a legally marketed device.

Does FDA Certification apply to cosmetics?

Cosmetics do not require pre-market approval but must comply with FDA labeling and safety guidelines.

What are the FDA’s GMP requirements?

GMP includes practices for safe manufacturing, quality control, and documentation.

Can foreign companies sell FDA-approved products in the U.S.?

Yes, but they must register their facilities and appoint a U.S. agent.

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