Mandatory products that must be registered with the U.S. FDA

The United States is one of the most demanding and highly regulated markets in the world, especially in sectors like food, cosmetics, and medical devices. One of the first and most critical requirements for businesses looking to enter this market is registering with the FDA – the U.S. Food and Drug Administration. So which are the mandatory products that must be registered with the FDA to access the U.S. market?

Mandatory products that must be registered with the U.S. FDA
Mandatory products that must be registered with the U.S. FDA

Consumer goods – mandatory products that require FDA registration

The FDA oversees a wide range of products that directly impact public health. If your business manufactures, processes, packs, or distributes food, beverages, cosmetics, medical devices, or dietary supplements for export to the U.S., registration is mandatory. This ensures that your products meet FDA standards for safety, labeling, hygiene, and traceability.

It’s not just traditional food items like snacks, beverages, or spices – emerging products such as collagen, organic food, or functional supplements are also mandatory products under FDA oversight. The FDA does not differentiate by factory size or production method – as long as the product enters the U.S. market, the business is legally responsible for compliance.

Consumer goods – mandatory products that require FDA registration
Consumer goods – mandatory products that require FDA registration

Cosmetics and medical devices: Product categories you can’t overlook

Cosmetics have specific regulations because they are used directly on the skin, hair, lips, or body. While FDA certification is not required before import, businesses must still register their facilities and ensure products are free from banned substances and labeled correctly in accordance with FDA guidelines.

Medical devices – from simple items like surgical masks and gloves to complex equipment like ultrasound machines or ventilators – must be classified and registered according to their risk level. Some devices require a 510(k) submission or premarket approval (PMA). Failure to comply can lead to immediate import refusal at U.S. ports.

Cosmetics and medical devices: Product categories you can't overlook
Cosmetics and medical devices: Product categories you can’t overlook

Don’t let oversight block your market entry

In practice, many Vietnamese businesses face risks simply because they are unaware whether their products fall under the mandatory product category for FDA registration. There have been cases where shipments were returned because the manufacturing facility wasn’t properly registered, or the labeling didn’t meet FDA standards – even when the product quality was acceptable.

That’s why carefully reviewing and correctly identifying whether your products are mandatory products before exporting to the U.S. is critical. Don’t confuse “FDA certification” with “FDA registration” – the FDA does not issue conventional certificates but acknowledges registration and compliance with proper standards and procedures.

Don’t let oversight block your market entry
Don’t let oversight block your market entry

-> Learn more: FDA Certification: The mandatory certification for exporting goods to the U.S.

MettiFDA – Supporting your export journey from day one

With years of experience helping Vietnamese businesses comply with FDA regulations, MettiFDA deeply understands the specific requirements and processes for each product category. From product assessment and registration documentation to label review and inspection readiness, MettiFDA is committed to giving businesses peace of mind as they expand into the U.S. market.

MettiFDA – Supporting your export journey from day one
MettiFDA – Supporting your export journey from day one

Conclusion

The FDA is not just a regulatory agency – it is a technical barrier that determines whether your product can enter the U.S. Identifying mandatory products that require FDA registration and ensuring full compliance can save your business time, money, and legal trouble. Along this journey, working with a specialized consulting partner like MettiFDA is the key to successfully navigating one of the world’s most challenging yet promising markets.

—————————————————-

Contact Us