US FDA Approval the word has so much value, and across the Globe, manufactures 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.
US FDA Approval of Drugs
US FDA Approval of 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 CDER is challenging and time consuming.
Once completion of US FDA Approval of drugs, it can be sold in the US market after establishment registration and Listing.
The final approval will come for a drug molecule after Preclinical Testing, Investigational New Drug Application, Clinical Trials, NDA Application, Drug Labeling, Facility Inspection, and finally, approval.
Currently, we are NOT providing US FDA Approval of drugs service for generic drugs. We provide registration and listing for the below category of items,
- OTC Drugs.
- Testing Laboratories.
- Active Pharmaceutical Ingredients.
US FDA Approval of Food & Food Supplements
US FDA Approval of 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 addictives.
Currently, we are NOT providing the above FDA Approval service for Food manufactures. We offer the following services for food / dietary supplement / Nutraceutical manufactures across the Globe.
- Food Facility Registration.
- Food Testing.
- Food Label Review.
- GMP Implementation
- FDA Pre & Post Inspection Service
US FDA Approval for Medical Device
US FDA Approve only non exempted medical devices. The majority of the Class I devices are exempt, and NO approval required.
Class II & Class III devices have to follow PMA or 510k approval before marketing the device in the USA.
- More details about 510k.
- More Information about exempted device registration & Listing.
US FDA Approval for Cosmetics
- Voluntary Cosmetic Registration Program (VCRP)
- Cosmetic Ingredient Statement Filling
- Cosmetic Product Label review
- US FDA Agent Service
US FDA Approve not required for the distribution of Cosmetics in the USA. We provide the following service for the sale/export of Cosmetics to the USA.