FDA & Certificate
Your Gateway to FDA Compliance and Global Success
The FDA (U.S. Food and Drug Administration) oversees and certifies products such as food, drugs, cosmetics, and medical devices imported into the United States.
01.
Food Certifications
Food Facility Registration
Required for all production or processing facilities exporting food to the U.S. to ensure food safety and traceability.
Food Labeling Review
Ensures compliance with U.S. standards for ingredients, nutritional facts, and allergen statements.
Food Contact Material Certification (FCM)
Ensures that materials in direct contact with food meet FDA safety standards.
HACCP Certification
Required for seafood and juice manufacturers, focusing on risk management during production.
02.
Drug Certifications
ANDA (Abbreviated New Drug Application)
A streamlined approval process for generic drugs.
NDA (New Drug Application)
Required for innovative drugs, involving detailed clinical trial and toxicology data submission.
OTC Drug Certification
Over-the-counter drugs can enter the U.S. market through FDA’s OTC drug approval, primarily for low-risk, commonly used drugs.
03.
Medical Device Certifications
510(k) Certification
Applies to Class II and some Class III medical devices, proving that the product is substantially equivalent to an existing marketed device.
PMA (Premarket Approval)
Required for high-risk Class III devices, supported by clinical data.
De Novo Application
For new, low- to moderate-risk devices without a substantially equivalent product on the market, requiring FDA's independent review.
