"FDA registered" is not "FDA approved": what FDA's own pages say

Registering a facility with FDA and receiving a registration number is not the same as FDA approving the product. FDA's consumer page "Is It Really 'FDA Approved'?" states that "mere registration of an establishment or listing of a drug or device does not denote approval of the establishment, the drug or device, or other drugs or devices of the establishment, nor does it mean that a product may be legally marketed." 21 CFR 807.39 puts the point in regulation text for devices, and FDA's cosmetics statement says the agency does not provide certificates or other documents to verify compliance for cosmetic product facility registration. Those three sources settle the question that a supplier's registration paperwork cannot settle for you.

What FDA says registration does not mean

• FDA's "Is It Really 'FDA Approved'?" page: mere registration of an establishment, or listing of a drug or device, does not denote approval, and does not mean the product may be legally marketed.
• 21 CFR 807.39: "Registration of a device establishment or assignment of a registration number does not in any way denote approval of the establishment or its products." The next sentence adds that any representation creating an impression of official approval because of registration or possession of a registration number is misleading and constitutes misbranding.
• FDA's cosmetics statement, "FDA Clarifies It Does Not Provide Certificates or Other Documents to Verify Compliance for Cosmetic Product Facility Registration": the agency informs cosmetic product facilities, retailers and industry responsible persons that it does not provide certificates or other documents to verify compliance for cosmetic product facility registration.

One related provision sits in 21 CFR 807.97, which concerns premarket notification rather than registration: any representation that creates an impression of official approval of a device because of complying with the premarket notification regulations is misleading and constitutes misbranding.

Who registers

The "Is It Really 'FDA Approved'?" page states that unless an exemption applies (like domestic manufacturing facilities), drug, foreign food, and most device facilities must register with FDA before exporting products to the U.S.

The registration rules for device establishments sit in 21 CFR 807.22 and 807.40:

Provision	What it says
807.22(a)	An owner or operator of an establishment who has not previously entered into an operation described in § 807.20(a) shall register within 30 days after entering into such an operation and submit device listing information at that time.
807.22(b)(1)	Annual registration for each fiscal year is required for all establishments.
807.40(a)	Any establishment within any foreign country engaged in the manufacture, preparation, propagation, compounding, or processing of a device that is imported or offered for import into the United States shall register such establishment and list such devices using the FDA electronic device registration and listing system.
807.40(b)	Each foreign establishment shall designate only one United States agent and may designate the United States agent to act as its official correspondent.
807.40(c)	No device may be imported or offered for import into the United States unless it is the subject of a device listing as required under subpart B of this part and is manufactured, prepared, propagated, compounded, or processed at a registered foreign establishment; this restriction does not apply to devices imported or offered for import under the investigational use provisions of part 812 of this chapter.
807.40(d)	The device establishment registration and device listing information shall be in the English language.

What FDA does and does not approve

The "Is It Really 'FDA Approved'?" page describes several separate things that are often blurred together.

Manufacturing facilities: although such facilities and contract manufacturers are often inspected as part of a product application for certain products that require premarket approval, and are frequently required to register, the agency does not approve manufacturing facilities independently.

Class II devices: generally, manufacturers of moderate-risk medical devices (Class II), such as dialysis equipment and many types of catheters, may market such devices pursuant to so-called 510(k) clearance, allowing distribution once the manufacturer has demonstrated substantial equivalence to a legally marketed predicate device that does not require premarket approval.

Cosmetics: cosmetic products and ingredients, and their labeling, do not require FDA approval.

Dietary supplements: by statute, the FDA does not approve dietary supplements for safety and effectiveness.

Food labels: the FDA does not approve individual labels before food products, including dietary supplements, can be marketed.

The FDA logo: the page states that the logo is for official government use only, and should not be used to misrepresent the agency or to suggest that the FDA endorses any private organization, product, or service.

510(k) clearance

FDA's "Premarket Notification 510(k)" page describes 510(k) as a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act).

The page sets out timing and format conditions:

• Until the submitter receives an order declaring a device SE, the submitter may not proceed to market the device.
• The SE determination is usually made within 90 days and is based on the information submitted by the submitter.
• Starting October 1, 2023, all 510(k) submissions, unless exempted, must be submitted as electronic submissions using eSTAR.
• After May 28, 1976, the effective date of the Medical Device Amendments to the Act, anyone who wants to sell a device in the U.S. is required to make a 510(k) submission at least 90 days prior to offering the device for sale, even though it may have been under development or clinical investigation before that date.

The page lists who submits: foreign manufacturers/exporters or U.S. representatives of foreign manufacturers/exporters introducing a device to the U.S. market are among the parties covered.

For an importer, the same page sets out an exception. In the situation described as "the device is made outside the U.S. and you are an importer of the foreign made medical device," a 510(k) is not required if a 510(k) has been submitted by the foreign manufacturer and received marketing clearance.

Two further statements on the page: FDA does not typically perform 510(k) pre-clearance facility inspections, and FDA charges a fee for review of Premarket Notifications [510(k)].

Cosmetics

FDA's cosmetics statement addresses registration and listing for cosmetics separately from approval. It says cosmetic product facility registration and cosmetic product listing is neither a cosmetic approval program nor a promotional tool, and that the assignment of a facility registration number or product listing number does not indicate FDA approval of the facility or its cosmetic products.

The statement lists "a certificate as proof of cosmetic product facility registration or cosmetic product listing" among the documents the agency does not provide to verify compliance.

It also notes a practical situation the agency has seen: the FDA is aware that ecommerce platforms, such as TikTok Shop, may ask those wanting to sell their products on these platforms to provide proof of FDA registration or, if they are not required to register with FDA, a letter or email from FDA confirming such a registration exemption.

Questions people ask

Can I get a certificate from FDA showing my cosmetic product facility is registered?

FDA's statement says the agency does not provide certificates or other documents to verify compliance for cosmetic product facility registration. Cosmetic product facility registration and cosmetic product listing is neither a cosmetic approval program nor a promotional tool, and a registration number or listing number does not indicate FDA approval.

A supplier sent a registration number. Does that mean FDA approved the product?

The "Is It Really 'FDA Approved'?" page says mere registration of an establishment or listing of a drug or device does not denote approval, and 21 CFR 807.39 says registration of a device establishment or assignment of a registration number does not in any way denote approval of the establishment or its products.

Sources

• Is It Really 'FDA Approved'?, U.S. Food and Drug Administration
• FDA Clarifies It Does Not Provide Certificates or Other Documents to Verify Compliance for Cosmetic Product Facility Registration, U.S. Food and Drug Administration
• PART 807—ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES, eCFR (Office of the Federal Register / GPO)
• Premarket Notification 510(k), U.S. Food and Drug Administration

Checked 11 October 2026.

This page is an unofficial summary, is not affiliated with the U.S. Food and Drug Administration, and the official text governs.