When discussing medical devices regulated by the United States Food and Drug Administration (FDA), words such as “approved” and “cleared” cannot be used interchangeably because these terms have a special meaning. Similarly, it is also prohibited to create an impression of endorsement of a device establishment or its devices because the establishment is registered with the FDA. The long-standing regulatory provisions, 21 CFR § 807.97 and 21 CFR § 807.39, state, respectively, the FDA’s position that approval and clearance are not interchangeable and that device establishment registration does not imply endorsement of the establishment or its devices. Importantly, these provisions also highlight the implications for industry of the misuse of terms when considering the regulatory status of a device or 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 applicant must obtain a substantial equivalence order from the FDA, which is usually referred to as 510(k) permission. Conversely, to market a new device for which a premarketing approval application must be submitted to the FDA, the applicant must obtain FDA approval. approval demand. Although FDA review and action occurs for both types of medical devices, the results of clearance and approval are markedly different and carry legal consequences. Specifically, 21 CFR § 807.97 states that “[a]Any representation that gives the impression of an official endorsement of a device due to compliance with premarket notification regulations is misleading and constitutes poor branding. Additionally, 21 CFR § 807.39 states that “[a]any representation that creates the impression of official endorsement by reason of registration or possession of a registration number is misleading and constitutes poor brand image. »
We searched the FDA’s Warning Letter Database for warning letters and found that the FDA had 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 the FDA found to be misleading under 807.97 were simple violations, such as language on product websites indicating that authorized devices are “FDA-approved” or authorization listings. of devices under “FDA Approvals”. In one case, the FDA found the website to be misleading under § 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-exempt device. (k) for an indication that would require de novo clearance which the company had not obtained, and the website claimed that the company maintained an active list, which was hyperlinked to the FDA establishment registration and device list company only for 510(k) exempt device.
In response to the COVID-19 public health emergency, the FDA issued twelve warning letters regarding representations regarding masks and antibody tests that were found to be misleading under Section 807.39. In virtually all of these cases, the companies’ websites displayed unofficial “FDA Registration Certificates” issued by third parties that purported to certify that the manufacturer had completed establishment registration and device listing with the FDA. FDA. These certificates often incorporated unauthorized reproductions of the FDA logo and US flag designs, giving the impression of official government documents. The FDA has consistently found the display of these certificates to be misleading, even when they included conspicuous “disclaimer” language stating that the certificates did not denote FDA endorsement or approval. The FDA has repeatedly found that these disclaimers do not adequately limit or mitigate the misleading impression of certificates because they are worded, designed, and placed in such a way that they can be easily ignored.
These warning letters present a warning to all sponsors intending to commercialize new medical devices. While sponsors may be tempted to claim their devices are FDA-approved after the agency’s review of a premarket notification or termination of establishment registration and list of FDA devices, § 807.97 and § 807.39 make it clear that such claims will constitute poor brand image. Sponsors can avoid § 807.97 and § 807.39 warning letters and associated liability by carefully reviewing all language in their marketing materials and websites to ensure that none of their representations gives the impression official approval based on reference to a pre-market notification. or establishment registration.
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