FDA Cleared vs Approved

FDA uses four distinct words for premarket dispositions, and each carries a specific legal meaning. 'Cleared' applies to Class II medical devices that have completed 510(k) Premarket Notification review and received a substantial-equivalence (SE) determination. 'Approved' applies to Class III medical devices that have completed PMA review, to new drugs that have completed NDA review, and to biologics that have completed BLA review. 'Granted' applies to devices that have completed a De Novo classification request. 'Authorised' applies to products under Emergency Use Authorization (EUA).

The distinction is not stylistic. Section 502(o) of the FD&C Act and 21 CFR 807.97 make it a misbranding violation to represent that 510(k) clearance constitutes FDA approval. The agency's standard warning-letter language: 'Any representation that creates the impression of official approval of a device by the agency because of the existence of a 510(k) is misleading and constitutes misbranding.' That language has been recycled into hundreds of warning letters since 1996.

The words reflect what FDA decided. A 510(k) clearance is a comparison decision — the device is substantially equivalent to a legally marketed predicate. FDA has not made a finding that the device is safe and effective in absolute terms; it has found that the device is at least as safe and effective as the predicate. That is a meaningful conclusion, but it is not equivalent to an affirmative safety-and-effectiveness determination.

A PMA approval is an affirmative determination of reasonable assurance of safety and effectiveness based on the device's own evidence. The clinical evidence, manufacturing controls and post-market commitments were independently reviewed and accepted. The same standard underlies NDA approval for drugs and BLA approval for biologics, with statutory definitions specific to each product type.

De Novo is a hybrid — the device is novel (no predicate) but FDA has classified it into Class I or II with appropriate controls. The legally correct verb is 'granted'; the device is 'De Novo granted' or 'authorised'. It is not approved, and not strictly cleared.

Some additional verbs appear in adjacent FDA programmes. Cosmetics are not subject to premarket approval (MoCRA introduced registration and listing in 2023 but not premarket review). Medical food, infant formula, and food additives have their own statutory frameworks with distinct terminology. When in doubt, mirror the language in the disposition letter itself — that letter is the legally controlling instrument.

Three rules cover almost every consumer-facing claim. First, never use 'FDA-approved' for a cleared device, in any medium — packaging, package insert, website, social media, sales literature, trade-show signage, paid advertising. Second, avoid composite phrasing that creates the impression of approval — 'reviewed by the FDA', 'FDA-evaluated', 'FDA-recognised' are all suspect unless they precisely describe the actual disposition. Third, when stating the disposition, be specific: '510(k) cleared by FDA in 2024 under K241234' is unambiguous and defensible.

FTC enforcement applies in parallel to FDA. The FTC's 2022 Health Products Compliance Guidance requires competent and reliable scientific evidence for any claim about health benefits or product performance. A truthful '510(k) cleared' statement still has to be accompanied by competent evidence for the specific clinical claim being made in the advertisement.

• OTC drugs marketed under an FDA OTC monograph are not 'FDA-approved' per se — the monograph itself is approved. Claim 'made in accordance with the OTC monograph for X'.
• Devices marketed under enforcement discretion (e.g. certain digital-health enforcement-discretion categories) are neither cleared nor approved. Saying either is a misrepresentation.
• Combination products may have one constituent cleared and another approved — describe each constituent precisely rather than aggregating.
• EUAs are time-limited and revocable. 'FDA-authorised' should be qualified with the EUA-specific intended use; the authorisation ends when FDA terminates the EUA or the underlying public-health emergency ends.
• Software updates to a cleared 510(k) device can shift the cleared scope. Verify the current cleared labelling before the next advertising cycle.

If the mistake is on your own marketing, correct it. Pull the offending material, issue corrected copy with the right language, and document the change-control event in your QMS. If a third party (distributor, reseller, online marketplace) made the misrepresentation, send a written correction notice and keep records — FDA expects manufacturers to police downstream channels. If FDA has already issued a Form 483 or warning letter, the response must include both the immediate correction and a systemic CAPA addressing how the claim got through your promotional-materials review process.

Cosmetic 'cleared vs approved' slips are the easiest to fix early and the most expensive to ignore. A consistent promotional-materials review SOP — with a final marketing-claims gate that explicitly checks disposition language against the source letter — eliminates the most common cause.