On November 25, 2013, the Food and Drug Administration (FDA) finalized its June 1, 2011 draft guidance on RUO/IUO IVDs, omitting the most controversial intended use language in response to comments, but retaining a broader interpretation of intended use than had been advocated by some manufacturers. The final guidance also revives the “certification” concept, but with a different rationale than originally proposed in a decades-old draft FDA policy statement. In light of the final guidance, manufacturers should review their commercial practices for RUO/IUO IVDs, including the need for certification programs.
In the final guidance, FDA eliminated:
- The assertion that a customer’s clinical intended use for a properly-labeled and marketed research use only (RUO) or investigational use only (IUO) IVD could be deduced solely based on the manufacturer’s actual knowledge or “reason to know” of clinical use by its customers.
- The recommendation that manufacturers halt sales of RUO-labeled IVDs to laboratory customers they discover are using the products in clinical diagnosis.
Manufacturers and other stakeholders had submitted comments to FDA arguing that the draft guidance (1) exceeded the scope of the agency’s statutory authority; (2) would require manufacturers to “police” the uses of IVD products by customers; and (3) would restrict patient access to important diagnostic tests. In response to such concerns, Rep. Michael Burgess (R-TX) earlier this year introduced legislation to establish a safe harbor for RUO manufacturers whose products were used for purposes other than research and to authorize certain “business communications” between manufacturers and users regarding properly-labeled RUO products.
The final guidance focuses on manufacturer statements and actions that would provide evidence of a clinical intended use for an RUO/IUO-labeled IVD, including not only promotional labeling and advertising, but also the “solicitation of business from clinical laboratories” by a manufacturer’s sales force that “makes routine calls to clinical laboratories that do not perform research or clinical studies. . . .”
The final guidance recommends that manufacturers “assess the totality of the circumstances surrounding the sale and distribution” of their RUO/IUO products. The guidance also notes that use of a “certification program”—under which users certify that they will not use RUO/IUO products in a “manner inconsistent with the labeling”—may be a factor in assessing intended use, but cautions that certification does not “relieve manufacturers of their responsibility” to ensure that their labeling and distribution practices are consistent with the product’s labeling.
In a 1989 draft policy guidance, FDA had “strongly encourage[d]” manufacturers of RUO/IUO IVDs to establish certification programs to demonstrate their compliance to FDA. Notwithstanding FDA’s lack of statutory and regulatory authority to require such certification, some manufacturers have interpreted the 1989 draft, in effect, to require certification to demonstrate compliance when selling RUO/IUO products. The final guidance, in contrast, identifies certification solely as a means by which a manufacturer may evaluate its own compliance, and not as a way to demonstrate compliance to FDA.