How to Get FDA Approval

"FDA Approved" is a common term used on product labels, especially products marketed on internet sites. Do they are really approved by FDA? FDA approves a product only after reviewing its safety and effectiveness. Most products do not require FDA approval to market in the USA; only FDA registration is required. Also, the FDA does not approve manufacturing establishments; the FDA may conduct an audit/inspection against GMP compliance. A successful FDA audit/inspection without any non-compliance does not mean FDA approval of the establishment.

FDA Approval for Food

FDA does not approve food or food facility. Food facilities must register with FDA and list product categories. FDA will assign an 11-digit registration number immediately after a successful registration. Food labels must comply with FDA label requirements, but it is the manufacturer/distributor’s responsibility to make sure product labels are in full compliance; FDA will not review and approve food labels.

New food additives, new dietary ingredients, and some color additives are exemptions for the above, requiring FDA approval to market.

FDA approval for Dietary Supplement

The dietary supplement does not need FDA approval; only new dietary ingredients need FDA approval. Facility registration, GMP, label, and ingredient compliance are the requirements.

FDA Approval for Medical Devices

Generally, Class I and Class II medical devices do not require FDA approval; most Class III devices require FDA approval to market in the USA. Class II medical devices require only a marketing clearance from FDA (510k), which is not an approval. Most class I devices have only general controls. All medical device establishments require FDA registration and device listing.

FDA approval for cosmetics

FDA does not approve cosmetics or cosmetic products, but the establishment requires FDA registration and cosmetic product listing to market in the USA. Cosmetics must comply with label and ingredient requirements.

FDA approval for Drug

Drug products complying with OTC Monograph do not require FDA approval; other drugs require NDA or ANDA approval. Homeopathic drugs complying with HPUS don’t need FDA approval. FDA Registration, NDC labeler code, drug listing, and label compliance are standard requirements for all drugs.

FDA Clearance         FDA Approval


For more information about how to get FDA Approval or FDA Certification, please contact us at

Certificate of FDA Registration

LMG assists foreign and domestic facilities to register with FDA. We also provide US FDA Agent service to foreign facilities. Please complete our online form to register your facility with FDA.

Proof of FDA Registration

LMG issues a free FDA registration certificate after successfully completing your facility registration with FDA. You can use this certificate as proof of FDA registration to the industry. Also, you can verify certificate validity on our website.

FDA Certificate