How to Get FDA Approval

“FDA Approved” is commonly used on product labels — but most products do not require FDA approval to market in the USA. Understand the difference between FDA registration, approval, and certification.

Registration vs ApprovalAll Product TypesExpert GuidanceSince 2009

FDA Approval vs FDA Registration — What You Actually Need

"FDA Approved" is a common term used on product labels, especially products marketed on internet sites. But are they 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.

Food & Food Facilities: FDA does not approve food or food facilities. Food facilities must register with FDA and list product categories. Food labels must comply with FDA label requirements, but the manufacturer/distributor is responsible for compliance — FDA will not review and approve food labels.

Cosmetics: FDA does not approve cosmetics or cosmetic products, but establishment registration and product listings are mandatory under MoCRA. Cosmetics must comply with label and ingredient requirements.

OTC Drugs: Drug products complying with OTC Monograph do not require FDA approval. FDA registration, NDC labeler code, drug listing, and label compliance are standard requirements for all drugs. Other drugs require NDA or ANDA approval.

Medical Devices: The FDA may conduct an audit/inspection against GMP compliance. A successful FDA audit/inspection without non-compliance does not mean FDA approval of the establishment. Most devices require either 510(k) clearance (substantial equivalence) or Premarket Approval (PMA) depending on classification.

LMG assists foreign and domestic facilities to register with FDA and provides US FDA Agent service to foreign facilities. LMG issues a free FDA registration certificate after completing registration — verifiable at fdahelp.us.

Frequently Asked Questions

Common questions about this FDA service.

Does FDA approve food products?

No. FDA does not approve food or food facilities. Food facilities must register with FDA and comply with labeling requirements.

Does FDA approve cosmetics?

No. FDA does not approve cosmetics or cosmetic products. However, establishment registration and product listings are mandatory under MoCRA.

Do OTC drugs need FDA approval?

Drug products complying with OTC Monograph do not require FDA approval. Other drugs (NDA/ANDA drugs) require FDA approval.

Does FDA certification mean FDA approval?

No. FDA registration or registration number does not denote FDA certification or approval of your facility or products.

What is the difference between 510(k) clearance and PMA?

510(k) clearance (Premarket Notification) demonstrates substantial equivalence to a predicate device. PMA (Premarket Approval) is required for Class III devices and requires proof of safety and effectiveness.