On October 2, 2014 FDA issued its “Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories: Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” (“LDT Guidance”) to clarify FDA’s enforcement objectives with regard to LDTs. An LDT is a subset of in vitro diagnostic devices (“IVDs”), and FDA will consider an IVD an LDT when it is used, designed, and manufactured by only a single laboratory. Since 1976, when the U.S. Congress amended the Food Drug and Cosmetics Act (“FD&C”) and made explicit that IVDs were devices under the Act, FDA has generally exercised enforcement discretion with respect to LDTs.
Under the current regulatory scheme, The Centers for Medicare and Medicaid Services (“CMS”) regulates laboratories under the Clinical Laboratory Improvement Amendments (“CLIA”), but not LDTs or their accuracy. In the LDT Guidance, FDA notes its “concerns regarding the lack of independent review of the evidence of clinical validity of LDTs,” and indicates the Agency’s intent to phase select categories of LDTs into the regulatory curtilage of devices.
Reference is made to the role of institutional review boards (“IRBs”) as they relate to studies of LDTs. For clinical investigations of LDTs conducted under clinical protocols requiring IRB approval, the Draft Guidance indicates the Agency’s intent to continue its enforcement of investigational device requirements under 21 CFR Part 812. For IVD studies not exempt from Part 812, the IRB will make a device risk assessment as part of its study review. Language within the Draft Guidance tracks language from the “Criteria for IRB Approval of Research” found in 21 CFR 56.111 as well as elements of informed consent found in regulations governing protection of human subjects at 21 CFR 50.25, further highlighting the IRB’s role of ensuring that subjects have adequate information to make an informed decision about participation in clinical research involving LDTs.
While studies of many LDTs may be exempt from 21 CFR 812’s requirements, research participants must still be apprised of the investigational nature of unapproved medical devices as well as alternatives to study participation. As changes to FDA’s LDT oversight framework take effect, Sterling will continue to focus on unique issues impacting the welfare of participants in studies involving LDTs. If you would like to learn more about Sterling services, please contact the IRB.
Article submitted by Royce DuBiner, JD, LLM