Avoiding Misbranding: Words Matter When Describing the Regulatory Status of 510(k) Cleared Devices and Registered Device Establishments


When it comes to discussing medical devices regulated by the U.S. Food and Drug Administration (FDA), words such as “approved” and “cleared” cannot be used interchangeably as these terms carry a particular meaning. Similarly, creating an impression of approval of a device establishment or its devices because the establishment is registered with FDA also is prohibited. Long-standing regulatory provisions, 21 C.F.R. § 807.97 and 21 C.F.R. § 807.39, set forth, respectively, the FDA’s position that approval and clearance are not interchangeable and that device establishment registration does not denote approval of the establishment or its devices.  Importantly, these provisions also highlight the consequences to industry for misusing terms when discussing the regulatory status of a device or a device establishment.

When seeking to market a new device for which a premarket notification must be submitted to the FDA demonstrating that the device to be marketed is substantially equivalent to a legally marketed device, the submitter must obtain an order of substantial equivalence from the FDA, which is commonly referred to as a 510(k) clearance. Conversely, to market a new device for which a premarket approval application must be submitted to the FDA, the applicant must obtain FDA’s approval of the application. While FDA review and FDA action occur for both types of medical devices, the outcomes of clearance and approval are distinctly different and carry legal consequences. Specifically, 21 C.F.R. § 807.97 states that “[a]ny representation that creates an impression of official approval of a device because of complying with the premarket notification regulations is misleading and constitutes misbranding.” Additionally, 21 C.F.R. § 807.39 states that “[a]ny representation that creates an impression of official approval because of registration or possession of a registration number is misleading and constitutes misbranding.”

We researched Warning Letters in FDA’s Warning Letter Database and found that FDA issued four Warning Letters citing violations of § 807.97 since 2017 and thirteen Warning Letters citing violations of § 807.39 since 2017.

Many of the representations that FDA found to be misleading under § 807.97 were straightforward violations, such as language on product websites stating that cleared devices are “FDA approved,” or listings of device clearances under the heading “FDA Approvals.” In one instance, FDA found the website to be misleading under both § 807.39 and § 807.97 because the company claimed the device had been cleared by the FDA, when in fact it was marketing a 510(k) exempt device for an indication that would require a de novo authorization which the company had not obtained, and the website claimed the company maintained an active listing, which was hyperlinked to the company’s FDA Establishment Registration and Device Listing for only the 510(k) exempt device.

In response to the COVID-19 public health emergency, FDA issued twelve Warning Letters related to representations regarding masks and antibody tests that were found to be misleading under § 807.39. In virtually all of these instances, company websites displayed unofficial “certificates of FDA registration” issued by third parties which claimed to certify that the manufacturer had completed FDA Establishment Registration and Device Listing. These certificates often incorporated unauthorized reproductions of FDA’s logo and motifs of the U.S. flag, giving the impression of official government documents. FDA consistently found the display of these certificates to be misleading, even when they included ostensible “disclaimer” language stating that the certificates did not denote FDA endorsement or approval. FDA repeatedly found that these disclaimers did not adequately limit or otherwise mitigate the misleading impression of the certificates because they were phrased, designed, and placed in a manner where they could be easily overlooked.

These Warning Letters present a cautionary tale to all sponsors intending to market new medical devices. While sponsors may be tempted to claim their devices are approved by the FDA following the agency’s review of a premarket notification or upon completion of FDA Establishment Registration and Device Listing, § 807.97 and § 807.39 make clear that such claims will constitute misbranding. Sponsors can avoid § 807.97- and § 807.39-related Warning Letters and associated liability by carefully reviewing all of the language on their marketing materials and websites to ensure that none of their representations create the impression of official approval based on reference to a premarket notification submission or establishment registration.