FDA Food and Drug Administration

Protect public health by ensuring the safety, efficacy, and security of products and establishment by getting registration under FDA Certification in India.

What is FDA Certification?

The FDA/USFDA Food and Drug Administration compliance and approval are for the general protection of the customers and the end-users. The FDA approval is mandatory for some selected products for marketing in the USA and any relevant country, where it is to be used/consumed.

The FDA (company) is part of the United States Department of Health and Human Services considered as a federal agency.

FDA approvals are required to ensuring the safety of the following products:

  • vaccines
  • food
  • human drugs
  • dietary supplements
  • blood products and other biological
  • human drugs, veterinarian products
  • and tobacco products
  • medical devices
  • human drugs
  • Cosmetics being sold or manufactured in the United States.

Organizations that produce goods to export to the USA must fulfill the relevant cGMP standard as per FDA regulations.

FDA issues Form 483 after inspection by the inspection officer of FDA. After the completion of the inspection organization should adhere to the compliance of cGMP in India. FDA ensures the quality of the product and its effectiveness.

The FDA assesses and verifies many different things, including:

  • Certain new drugs, including biologics,
  • Some food additives for people and animals,
  • Some color additives in food, drugs, and cosmetics for people and animals,
  • Some medical devices

The FDA issues a warning letter if the management of the organization fails in the address and response of the Form 483 observations under FDA within the specified period time limit. Unsatisfactory response to the warning letter could lead to further actions like import alert for products and suspension or cancellation of manufacturing license.

What are the requirements for FDA Certification?

FDA certification or FDA Approval depends on the type of product, the manufacturer wants to export to the USA. All products don’t require FDA certification.

FDA Approvals or FDA Certification applies for both Facilities which are part of the relevant supply chain and for the Products as well. The following products, require FDA approvals and FDA Certification:

FDA for medical devices

FDA classifies the medical devices into three categories Class I, Class II, and Class III. All the classes of medical devices should follow General Controls for FDA approval. General Controls are the general requirements of the Food, Drug, and Cosmetic (FD&C) Act to get FDA approval. Class III are high-risk devices so must be demonstrated with FDA for its effectiveness and safety assurance whereas Class I and Class II posses low-risk devices may not require FDA approval (unless exempt under FD&C Act and required to submit the 510(k) Premarket Notification [510(k)] ensuring the safety and effectiveness of the device]). 

Though, (for Class I and Class II)- it is for the Organization to apply and get its facility and product, approval, and certification towards FDA.

FDA for cosmetics

Under FDA, the cosmetics may not need FDA approval except the color additives like hair dyes which must be approved under the FDA. Organizations are responsible for ensuring the safety of the product and providing reliable products for use for consumers. 

FDA for food 

FDA approval is not required for food to be distributed in the market of United States. But food facilities must be registered with FDA for approval. After registration, the FDA will provide with 11-digit registration number consisting of the label requirements under FDA. Adding a new ingredient or food/color additive requires FDA approval ensuring the safety of the product.

FDA for Drug products

Drug products new or old complying with OTC Monograph does not require FDA approval, other drugs new or old require FDA approval. Homeopathic drugs don’t need FDA approval because they are complying with HPUS. 

FDA for Dietary Supplements

Dietary Supplements do not require FDA approval. Only the additives require FDA approval for verifying the safety and compliance with the guidelines with the FDA.

FDA for tobacco 

An introduction to the product of tobacco into the market requires submitting a premarket application and registration and authorization under the FDA.

Why the FDA is important?

The USA is the global market leader for various manufacturers to export several pharmaceutical and other products. In the past few decades, the global market grew strongly and became the dominant provider of products, as listed above. Countries that don’t have their own independent FDA agency, might follow the regulations and guidelines as set by USFDA. FDA facilitates the hope of continual export to the United States.

Strength of Ascent WORLD

  • Ascent WORLD provides value-added solutions and processes to the various type of standards.
  • We perform our work with proper ethics and rules as per the compliance of the standard.
  • Our dedicated team of professionals provides you with a proper understanding and knowledge of the particular standard.
  • Our associates have more than 10+ years of experience in providing certification.
  • Ascent provides the gap analysis in a plan-do-check-act method of inadequate and available resources.
  • Respecting the client and its customer’s viewpoint and understanding the requirement is the main theme of Ascent Emirates to inculcate the process and procedure.

Our services include:

  • Conducting a Gap analysis.
  • Implementing relevant Good Manufacturing Practice (GMP) standards and guidelines for further inspection of FDA.
  • Guidance for conducting Pre-Approval Inspections Report (PAI).
  • Guidance for determining Quality Assurance and Control functions.
  • Guidance for Identifying Risks and conducting assessment and implementing Quality Risk Management Systems.
  • Guidance for implementing Study and Process Analytical Technology (PAT).
  • Guidance for doing Process and procedure validation.
  • Conducting USFDA Audit Readiness Training to employees and staffs.
  • Review of FDA Regulatory Submission including 510k.
  • Guidance for Inspectional Observations and Solutions in case, 483 form, and Warning Letters responses.

Frequently asked questions

Why FDA doesn't include dietary supplements?

Dietary supplements do not require the approval of the FDA. FDA’s Centre for Food Safety and Applied Nutrition is responsible for the FDA’s oversight of dietary supplements.  

Does the US require export certificates to export to foreign countries?

NO, the US does not require the export certificate to export products further to foreign countries.

What is the validity of FDA certification?

FDA is valid for a year from the issuing date and can be extended as per the payment and on request. FDA food facility registration is to be kept confidential from the general public.

What is the cost of FDA approval?

The cost of FDA approval depends on the type of product you want FDA approval.

How to achieve an FDA certificate?

To get FDA approval, relevant product manufacturers must implement a Quality Management System w.r.t. relevant GMP standards then, conduct all testing in the recognized and accredited lab and submit their data to the FDA. FDA will then review the data based on which it may or may not approve the product. If the agency (FDA) feels the data submitted is not relevant and may be risky for the intended use, it might not give approval / Certification.

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