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For Establishment Registration, 510k Submission, DMF submissions etc.

We are consultants and technical experts for 510k submissions

FDA Approval Process

FDA Approval

The US FDA plays a crucial role in safeguarding public health by verifying the safety, effectiveness, and security of drugs, biological products, medical devices, food, and cosmetics. The FDA approval process involves multiple stages to confirm that these products comply with the required standards before their distribution and sale in the United States.


US FDA Approval process the word has so much value, and across the Globe, manufacturers and their marketing partners claim their products are “FDA Approved” or they display words on the company’s website, or in commercial promotions like flex, magazines, and brochures.  It is not correct in 95% of cases. FDA never approves all the products sold in the USA.


FDA controls the distribution of drugs and biologics, animal drugs, medical devices, tobacco products, food (including animal food), cosmetics, and electronic products that emit radiation, and most of these are NOT approved or inspected by FDA before the start of marketing these products in the USA.

Contact us for US FDA Approval for Drugs, Medical Device, Food and Cosmetics

US FDA Approval For Drugs

US FDA Approval for drugs means it is determined to provide benefits that outweigh its known and potential risks for the intended population. The FDA drug approval process with the Center for Drug Evaluation and Research is challenging and time-consuming.


Once the US FDA Approves the drugs, they can be sold in the US market after establishment registration and Listing. The final approval for a drug is granted following preclinical testing, Investigational New Drug Application, clinical trials, NDA application, drug labelling, facility inspection, and ultimately, approval. Currently, we do NOT offer FDA Approval services for generic drugs. We do provide registration and listing for the following categories of items:

  • OTC Drugs.
  • Testing Laboratories.
  • Active Pharmaceutical Ingredients.

FDA Approval for Food and Supplements

US FDA Approval process for Food or beverages or dietary supplements neither Food manufacturing facilities do not have to obtain any approval before marketing in the United States. FDA Approval is required for Food Color and food additives.


Currently, we are NOT providing the above US FDA Approval services for Food manufactures. We offer the following services for food / dietary supplement / Nutraceutical manufactures across the Globe.

  • FDA Food Facility Registration.
  • Food Testing.
  • Food Label Review.
  • GMP Implementation
  • FDA Pre & Post Inspection Service

US FDA Approval for Medical Devices

US FDA Approval only for non-exempted medical devices. The majority of the Class I devices are exempt, and NO approval is required. Class II & Class III devices have to follow PMA or 510k approval before marketing the device in the USA.

  • More details about FDA 510k.
  • More Information about exempted device registration & Listing.

US FDA Approval Process for Cosmetics

The USFDA defines cosmetics as meant to be applied to the human body for cleansing, beautifying, enhancing attractiveness, or altering the appearance, without impacting the body’s structure or functions.


  • Cosmetic Facility Registration
  • Cosmetic Ingredient Statement Filling
  • Cosmetic Product Label review
  • FDA Agent Service


US FDA Approval is not required for the distribution of Cosmetics in the USA. We provide the following service for the sale/export of Cosmetics to the USA.

Are you looking to achieve US FDA approval for your products? Our expert team is here to guide you through the regulatory process for drugs, medical devices, food, and cosmetics. With our one-stop solution, we ensure your products meet all FDA requirements and standards.