By: Nazafat Jarrin
The Food and Drug Administration (“FDA”) distinctly defines the terms “FDA Approved” and “FDA Cleared.” Both terms are legally significant but often misunderstood by consumers in the advertising context. These terms don’t simply signify regulatory compliance for devices, but also convey information regarding the source of the product and consumer trust–two pillars of trademark law. Misuse of both terms and confusing consumers in advertising devices may result in false advertising claims under the Lanham Act and state consumer protection laws, raising the importance of true representation of regulatory compliance.
- “FDA Approved” vs. “FDA Cleared” Defined
The FDA classifies medical devices for marketing in three categories based on the degree of risk they present. As device classification increases from class I to class II to class III, the regulatory controls increase from least to most stringent. “FDA Approved” applies to new drugs and Class III medical devices. Under 21 C.F.R. Part 814, these drugs or devices require premarket approval (“PMA”) based on extensive testing. Before the FDA approves a PMA, the manufacturer must provide valid scientific evidence demonstrating reasonable assurances of safety and effectiveness for the device’s intended use. The “FDA Approval” label confirms that the product is safe and effective.
On the other hand, the label “FDA Cleared” applies to Class I and Class II medical devices via the 510(k) process. In the 510(k) process, the manufacturer must demonstrate that the new device is “substantially equivalent” to a predicate device in terms of intended use, technological characteristics, and performance testing, as needed. Some Class II devices are exempt from the 510(k) notification requirement if they do not exceed the limitations of exemption stated under the regulatory control the device is classified under.
The distinction between these two labels is important as the FDA regulates and monitors the sale of medical devices and this process ensures the safety of all regulated medical products. Understanding this difference is within the scope of responsibility of the device manufacturer. Failure to recognize the appropriate FDA framework for medical device markets can lead to legal repercussions that are avoidable if the manufacturers take the time to adhere to these labeling requirements.
- False Advertising Under the Lanham Act
Misrepresenting a medical device as “FDA Approved” when it is only “cleared” would trigger false advertising claims under § 43(a) of the Lanham Act (15 U.S.C. § 1125(a)). To bring a false advertising claim, the plaintiff must demonstrate that the defendant made false or misleading statements as to their products, actual or plausible deceives a substantial portion of the intended audience, the deception is material in that it is likely to influence purchasing decisions, the advertised goods travel in interstate commerce, and that there was a likelihood of injury to the plaintiff.
In the case of medical devices, labeling of “FDA Approved” when it is only “cleared” is a false statement and courts have strongly reinforced the materiality of health-related consumer misrepresentations. In industries regulated by the FDA, consumers and professionals place substantial weight on this regulatory status. Thus, the seemingly small discrepancy in saying “approved” instead of “cleared” may create a misleading impression of FDA endorsement, triggering Lanham Act liability. Such a statement inflates the manufacturer’s value as a source to the medical device through deception and violation of consumer trust, which undermines both fair competition and integrity of the market.
- State Consumer Protection Law Claims
In addition to federal law claims, state laws offer avenues for consumers to pursue misleading advertising claims. Federal and state trademark laws can run concurrently, and state laws are not preempted unless there is a direct conflict between the two. State consumer protection laws, like New York General Business Law §§ 349 and 350 and California’s Consumer Legal Remedies Act, can be broader as they provide for more consumer-focused protection, as well as protecting commercial competitors.
In the case of “FDA Approved” and “FDA Cleared,” federal law can preempt state law depending on which label was used and the severity of the violation. In Medtronic, Inc. v. Lohr, 518 U.S. 470, 493 (1996), the Supreme Court held that, “the scope of express preemption under § 360k(a) is typically limited to devices that have undergone the rigorous premarket approval (‘PMA’) process applicable to Class III devices. Devices cleared through the FDA’s less demanding § 510(k) process — most Class I and II devices — generally do not receive preemption protection because the 510(k) process does not impose ‘requirements’ sufficient to trigger § 360k preemption.” The Supreme Court later clarified in Riegel v. Medtronic, Inc, 522 U.S. 312, 330 (2008), that a “state my provide remedies for state-law claims premised on violations of FDA regulations.” As a result, the distinction between “FDA Approved” and “FDA Cleared” can determine whether state law claims are preempted or allowed to proceed.
- Compliance & Best Practices
Since the FDA primarily regulates labeling and advertising of drugs and devices under the Federal Food, Drug, and Cosmetics Act of 1938, 21 U.S.C. § 352, and thus it may issue warning letters to the appropriate party. The letter provides an opportunity for the company or individual to address FDA’s concerns and requests a response within a certain timeframe. However, competitors may be more likely to seek legal recourse through the Lanham Act or state consumer protection laws to challenge misleading advertisements and labeling, especially where the FDA lacks jurisdiction over broader marketing language.
To avoid warning letters, legal liability, and for the better good of consumer health, manufacturers should ensure that any mention of FDA status reflects the correct term between “approved” and “cleared.” They should also avoid the terminology altogether as it suggests FDA endorsement or efficacy when the device has not gone through PMA or the 510k process. Monitoring this compliance avoids the risk of regulatory penalties and false advertising claims under both federal and state law. Precision in this language is critical, not just for compliance, for ultimately for the integrity of medical devices in the marketplace.
References
Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).
Riegel v. Medtronic, Inc., 522 U.S. 312 (2008).
15 U.S.C. § 1125(a) (2022).
21 C.F.R. pt. 814 (2023).
21 U.S.C. § 360k (2022).
CITI Program, Understand the Difference Between FDA Cleared and FDA Approved Medical Devices, https://about.citiprogram.org/blog/understand-the-difference-between-fda-cleared-and-fda-approved-medical-devices/.
FDA, Device Advice: How to Study and Market Your Device, U.S. Food & Drug Admin., https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/how-study-and-market-your-device.
FDA, Is it Really ‘FDA Approved’?, U.S. Food & Drug Admin., https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved.
FDA, About Warning Letters and Close-Out Letters, U.S. Food & Drug Admin., (2024), https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/about-warning-and-close-out-letters.
Rebecca Hastings & Holger Liebig, Reducing Risk Through Mitigation Strategies, Applied Clinical Trials, (2009), https://www.appliedclinicaltrialsonline.com/view/reducing-risk-through-mitigation-strategies.