Marketing RUOs and IUOs
Under the Federal Food, Drug, and Cosmetic Act (FDCA), products intended to be used in “diagnosis” are subject to regulation as devices. FDA makes it clear in the draft guidance that simply labeling a product RUO or IUO is not sufficient to avoid regulation as a device. A product may bear an RUO or IUO label but be regulated as a device if it is marketed improperly. In that situation, FDA will deem the product to be an RUO IVD or IUO IVD.
This newly created—and somewhat confusing—nomenclature presumably describes products containing an RUO or IUO label that are, in fact, intended for diagnostic purposes.
A product intended for diagnostic use is an IVD, not an RUO or an IUO. Therefore, neither a product labeled RUO nor one labeled IUO may be promoted for diagnostic applications. While FDA has long made it clear that companies could not promote RUO and IUO products for diagnostic uses, the agency had never laid out specific parameters. The draft guidance document helps fill that void.
Under the draft guidance, a range of marketing activities can cause an RUO to forfeit that status. For example, companies selling an RUO product cannot make written or oral statements “that claim or suggest that the IVD product may be used in a clinical investigation or for any clinical diagnostic use” or that a laboratory can validate the product and “subsequently offer it for clinical diagnostic use as a laboratory developed test.” Furthermore, an RUO/IUO product can become an IVD because of “product names” (presumably this refers to a name implying diagnostic utility) or “clinical information” provided by the manufacturer.
FDA also says that it will consider the manufacturer's actions, not just its words. For example, “FDA may consider a manufacturer's knowledge of the purposes for which its customers offer and use its [RUO] product, and the manufacturer's provision of technical support for those activities.” Given that suppliers of RUO products are often asked by laboratories to provide product support, this statement by FDA could have significant practical ramifications both for laboratories and companies that sell laboratories RUOs. The restrictions enumerated on the marketing of IUO products essentially parallels the limits set out for RUO products.
To a large degree, these limits by FDA are consistent with the procedures many companies have adopted. This draft document reinforces the importance of carefully crafting marketing materials, including statements made by sales representatives, and of controlling technical support activities for laboratories. Diagnostic claims must be avoided. However, while the restraints on manufacturer-sponsored words and activities should not generate much controversy, that is not the case for another proposed restriction.