How to Start a FDA CERTIFICATION

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Overview of FDA Certification

The Food and Drug Administration (FDA), established in 1906 with the passage of the Federal Food and Drugs Act, is a government agency and the oldest consumer protection agency in the world. FDA certification is essential for products to be sold in the United States.

As a division of the U.S. Department of Health and Human Services, the FDA’s primary mission is to protect public health by ensuring the safety, efficacy, and security of human and biologically derived products. It regulates a wide range of items, including biological products, medical services, cosmetics, both prescription and over-the-counter medications, veterinary drugs, tobacco products, and other radiation-emitting devices.

Following an FDA inspection, Form 483 is issued as part of the certification process. According to FDA regulations, food and pharmaceutical manufacturing facilities in India must comply with Current Good Manufacturing Practices (CGMP). The FDA ensures the safety, quality, and effectiveness of medical and food products produced in India for export to the U.S.

What is FDA Certification and How Does it Work?

The FDA, a federal agency under the U.S. Department of Health and Human Services, is tasked with protecting public health by overseeing the safety and security of a wide range of products, including biological products, medical services, cosmetics, prescription and non-prescription drugs, veterinary medications, tobacco, and radiation-emitting devices.

CDSCO and FDA: Similarities

The Central Drugs Standard Control Organization (CDSCO) in India is equivalent to the FDA in the United States. It operates under the Ministry of Health & Family Welfare, Government of India, and serves as the national regulatory authority for pharmaceuticals and medical devices in India.

The Drug Controller General of India (DCGI), a department of CDSCO, oversees the manufacture, authorization, and sale of medical products, including medicines and medical devices in India. The DCGI is responsible for clinical research, evaluating the effects of products on human health, and enforcing the Drugs and Cosmetics Act. Inspections, audits, and surveillance are conducted by DCGI through zonal units across India.

 

FDA certification requirements depend on the type of product being marketed in the United States. Not all products require FDA approval, but certain categories do. Here’s a breakdown of which products require FDA certification:

FDA Certification for Food

While food products themselves do not need FDA certification before being sold, food facilities must be registered with the FDA. The FDA does not require certification for the products, but it does inspect food and pharmaceutical facilities to ensure they comply with regulations. These inspections can include visits to manufacturing plants in countries like India to verify adherence to FDA standards.

FDA Certification for Drugs

The FDA reviews whether a drug complies with the Over-the-Counter (OTC) monograph, which outlines conditions that ensure a drug is safe and effective for use. If a drug does not follow the OTC monograph, it requires FDA certification. In this case, drug manufacturers must submit data from laboratory, human, or animal testing to the FDA for review before receiving approval.

FDA Certification for Cosmetics

Cosmetic products and their ingredients, except for color additives, do not require FDA certification before they are marketed. Companies are not required to register their cosmetics with the FDA, but the products must be safe for consumer use. However, if a cosmetic product makes claims that could categorize it as a drug (e.g., therapeutic claims), it may require FDA approval.

FDA Certification for Color Additives

Color additives used in food, drugs, medical devices, and cosmetics require FDA certification. Some high-risk color additives necessitate color batch certification from the FDA. The FDA regulates the use of color additives to ensure they are safe for consumers and restricts harmful additives.

FDA Certification for Medical Devices

Medical devices are classified into three risk-based categories by the FDA: Class I, Class II, and Class III.

  • Class I: These devices pose minimal risk to the user, such as elastic bandages, face masks, and tongue depressors. Around 47% of medical devices fall into this category, and most are exempt from premarket FDA approval.

  • Class II: These devices carry a medium risk. They make up about 43% of medical devices and include items like motorized wheelchairs and some pregnancy test kits. Most devices in this category require premarket notification (510(k)) to the FDA.

  • Class III: These are the highest-risk devices, including pacemakers, breast implants, and replacement heart valves. They make up only 10% of devices and require FDA Premarket Approval (PMA). These devices must submit an application to demonstrate safety and effectiveness before approval.

Medical device manufacturers must register with the FDA and list their devices. However, registering and listing with the FDA does not automatically mean a product has received FDA certification. Manufacturers must still meet regulatory requirements for certification, especially for higher-risk devices.

In summary, FDA certification is required for drugs, certain medical devices, color additives, and sometimes cosmetics, depending on claims made. Food facilities must be registered, but food products themselves generally do not require FDA certification before being marketed.

Benefits of FDA Certification

Industry Impact
Achieving FDA certification can have a profound impact within your industry. While the process of obtaining FDA approval can be lengthy and involve multiple rounds of testing and revisions, the result is a product that significantly benefits consumers. Once approved, your product becomes available for purchase, improving the lives, health, and conditions of your target audience.

Increased Demand
FDA-approved products typically see a rapid increase in demand. Consumers trust that these products have been thoroughly tested for safety and efficacy, making them more likely to choose your product over others. Having the FDA's seal of approval often shifts a product from being a "nice-to-have" to a "must-have."

Access to Global Markets
FDA approval also grants you a Certificate of Foreign Government (CFG), which allows your product to be marketed and exported to international markets such as Japan, Brazil, Australia, and China. The FDA’s endorsement demonstrates to other countries that your product meets rigorous standards, facilitating access to broader global markets.

Enhanced Credibility
The FDA is a globally recognized authority, and receiving its approval boosts your product’s credibility. The approval process is known for its thoroughness, ensuring that only products that pass extensive testing and quality checks make it to market. Being FDA-approved signals to consumers and business partners alike that your product has been vetted for safety and effectiveness.

Opportunities for Business Expansion
Achieving FDA certification paves the way for your company to expand into new business areas. With FDA approval in hand, your company can more easily enter additional markets or industries, as your product’s proven quality and regulatory compliance will bolster your business reputation.

Improved Product Development
The process of obtaining FDA approval gives you a deeper understanding of how to create a high-quality product from the ground up. From design to testing and production, the steps involved emphasize safety and efficacy, helping you refine and advance your product over time.

Easier Access to Funding
FDA approval can also make it easier to secure funding. As an FDA-approved manufacturer, your company is seen as reputable and trustworthy, which attracts investors and partners looking to support growing businesses. Major companies often seek out smaller firms with FDA-certified products to expand their product lines.

Recognition in Medical Networks
For food or medical products, FDA approval is often required to be recognized and accepted by medical facilities, hospitals, and pharmacies. Without FDA clearance, you may face challenges in getting your products into these key channels. Additionally, the FDA approval process often involves working with medical networks for clinical trials and product testing, which can help you build valuable industry connections.

In summary, FDA certification not only boosts a product’s credibility and demand but also opens doors to international markets, funding opportunities, and long-term business growth. It ensures that your product meets the highest standards of safety and quality, benefiting both consumers and your company.

 

Documents Required for FDA Certification

General Documentation

  • Bill of Lading
  • Airway Bill
  • Invoice
  • Purchase Order

Product-Specific Documentation

  • Packing List
  • Growers List
  • Labeling Copies
  • Ownership Documentation – A statement identifying the actual owner of the product
  • Intended Use Statement – A declaration of the product’s intended or end use
  • Additional Documents – Any other documentation as requested by the FDA

These documents ensure that the FDA can verify the product’s details, its intended use, and compliance with relevant regulations.

Procedure for Obtaining FDA Certification

The FDA has the authority to inspect foreign food and drug manufacturing facilities that export products to the United States. For example, food and drug plants in countries like India must comply with the FDA's Current Good Manufacturing Practices (CGMP) guidelines. The FDA certification process generally follows these steps:

  1. FDA Inspection
    FDA officials visit foreign food and drug manufacturing facilities to assess compliance with regulatory standards.

  2. Issuance of Form 483
    After completing the inspection, the FDA issues Form 483 to the manufacturers. This form lists any deviations from FDA guidelines found during the inspection.

  3. Addressing Deviations
    If the FDA identifies regulatory deviations, they are documented in Form 483, which is then discussed with the management of the manufacturing company.

  4. Establishment Inspection Report (EIR)
    The FDA also provides an EIR, which outlines whether any further actions are required based on the inspection.

The overall process includes the following steps:

  • Pre-Clinical Testing
  • Investigational New Drug (IND) Application
  • FDA Review

  1. Response to Form 483
    Manufacturers are required to submit a detailed response to Form 483 within 15 working days. The response must address the identified shortcomings and provide an action plan to correct them.

  2. Warning Letter
    If the FDA is not satisfied with the response to Form 483, they may issue a warning letter. This letter must be addressed within 15 working days. Failure to respond satisfactorily can result in consequences such as cancellation of the manufacturing license, withholding product approval, or an import alert for the product.

  3. Final Approval
    Once the FDA is satisfied with the corrective actions and responses, the product is granted approval for import into the U.S.

In some cases, if the FDA identifies serious issues during the inspection, they may skip issuing Form 483 and directly issue a warning letter to the manufacturer.

This process ensures that all products entering the U.S. meet strict safety and quality standards.

Additional Regulatory Organizations

CDRH - The Center for Devices and Radiological Health
The Center for Devices and Radiological Health (CDRH) is a regulatory division within the U.S. FDA, part of the Department of Health & Human Services. It is responsible for enforcing laws and regulations related to radiation-producing electronic products, as well as medical devices such as lasers and light devices.

IEC - The International Electrotechnical Commission
The International Electrotechnical Commission (IEC) is a global standards organization that develops and publishes international standards for electrical, electronic, and related technologies, collectively referred to as ‘electrotechnology.’

ANSI - The American National Standards Institute
The American National Standards Institute (ANSI) is a private, nonprofit organization that oversees the development and dissemination of national standards in the U.S. While ANSI does not create standards itself, it supervises the process of creating voluntary standards across various industries, including manufacturing, services, and personnel. ANSI also ensures that U.S. standards align with international standards, facilitating the global marketability of U.S. products.

Why CA Anytime?

CA Anytime is a trusted platform designed to meet all your legal and financial needs, connecting you with reliable professionals. Our dedicated team of experts focuses on providing risk-based assessments that prioritize the health and well-being of the global population, while also minimizing regulatory risks for our clients.

Our professionals bring years of industry experience, specializing in International Quality System Regulations, Pharmaceutical and Medical Device Manufacturer Inspections, Biomedical Monitoring (BIMO), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP) audits.

Through our platform, clients can easily track the progress of their applications in real-time. If you have any questions regarding the FDA certification process, our experienced representatives are just a phone call away. CA Anytime ensures that your communication with professionals is smooth and efficient.

How the Process Works:

  1. Purchase a Plan for Expert Assistance
  2. Submit Queries About FDA Certification
  3. Provide Required Documents to CA Anytime Expert
  4. Prepare Application for FDA Certification and Meet All Preliminary Screening Criteria
  5. Complete All Procedural Steps
  6. Receive FDA Certification at Your Doorstep

With CA Anytime, the process is streamlined, efficient, and guided by experienced professionals to ensure a successful outcome.

Frequently Asked Questions

Form 483 is issued by FDA officials at the conclusion of an inspection when they identify conditions that violate FDA guidelines. The officials are required to document all observations in Form 483 in a clear, specific, and detailed manner.

Form 483 issued by the FDA notifies the company\\\'s management about any objectionable conditions found during the inspection. Following the inspection, Form 438 is provided and reviewed with the senior management of the company. The management is encouraged to submit a written response to Form 438, outlining the corrective action plan. This response should include a detailed plan for addressing the issues, and the implementation of the corrective actions should be carried out promptly.

After the inspection, Form 438 is reviewed and discussed with the company’s management. The FDA\\\'s observations listed in Form 438 are carefully examined to ensure a thorough understanding of the issues and their implications.

All color additives require prior FDA approval before being used in drugs, food, or cosmetics. The FDA grants a Color Certification for batches of color additives produced for use on or in humans and animals. These color batches undergo thorough analysis at designated facilities, and once they meet the required standards, the FDA issues the FDA Color Certificate.

The FDA certification is valid for one year from the date it is initially issued. The validity period can be extended upon request from the company.

A delay in the processing of food or drug product entries by the FDA may occur if the required entry paperwork is not provided.

To sell and distribute tobacco products, manufacturers must obtain a written order from the FDA. This order does not imply that the tobacco product is safe or FDA-approved. Instead, the marketing order confirms that the manufacturer has met all necessary requirements to bring the product to market.

If there are any questions regarding the submission of required paperwork, the local FDA office at the port of entry should be contacted.

The entry documents can be submitted to the FDA in the following ways:\r\nThe documents can be uploaded into ITACS (Import Trade Auxiliary Communication System) by the customs broker, importer, or any other responsible party. Alternatively, you can visit the contact page of the import office to find the local import division\'s postal address, email address, and/or fax number for submitting the documents.