Norton Rose Fulbright: FDA’s Expanded Oversight Of ‘High-risk’ Diagnostic Devices

Norton Rose Fulbright: FDA’s Expanded Oversight Of ‘High-risk’ Diagnostic Devices

By Cori Annapolen Goldberg and Lidia Niecko-Najjum

In efforts to ensure that in vitro diagnostic devices1 provide accurate, consistent and reliable results, the US Food and Drug Administration ("FDA" or "the Agency") 1) issued a final guidance on the development, review and approval or clearance of companion diagnostics and 2) notified Congress of its intent to publish "a proposed risk-based oversight framework for laboratory developed tests (LDTs) [a subset of in vitro diagnostic devices] which are designed, manufactured and used within a single laboratory." The FDA already oversees direct-to-consumer LDTs.

Companion in vitro diagnostics are tests used to identify patients who will benefit from or be harmed by treatment with certain drugs. They are intended to help physicians select appropriate therapies for individual patients. FDA's final guidance in turn is "intended to help companies identify the need for these tests during the earliest stages of drug development and to plan for the development of a drug and a companion test at the same time." In fact, FDA strongly encourages potential developers of LDTs to meet with both relevant device and therapeutic product review divisions as early in the development process as possible.

In the past, tests developed and sold by a single laboratory generally have not been subject to "pre-market" reviews. However, in recent years, certain LDTs have become highly specialized, widely used and broadly marketed without the required clinical studies to support their use, and they are sold in competition with FDA-approved tests.

Accordingly, FDA stated that the draft guidance intends to inform clinical laboratories that produce the most "high-risk" LDTs—that have the same intended use as FDA-approved or cleared companion diagnostics currently on the market—"the manner in which [these] laboratories may provide notification and comply with medical device adverse event reporting" required under the Federal Food, Drug, and Cosmetic Act ("FD&C Act").

FDA's notification describes FDA's priorities for enforcing pre-market and post-market requirements for LDTs and the process for phasing in FDA's enforcement. FDA assures that any new requirements will be phased in over years, while lower-risk diagnostics that include LDTs for rare diseases or conditions for which no other tests exist would be exempt from FDA's expanded oversight.

FDA has received criticism from university lab directors and the Academic Clinical Laboratory Association, which argue that FDA's regulation of the LDTs will slow the development of critical testing and "reduce patient access to the latest groundbreaking diagnostic advancements." Dr. Jeffrey Shuren, Director of the FDA's Center for Devices and Radiological Health, stated: "[w]ith today's notification of the agency's intent to issue the lab-developed test draft guidance, the FDA is seeking a better balanced approach for all diagnostics. The agency's oversight would be based on a test's level of risk to patients, not on whether it is made by a conventional manufacturer or in a single laboratory, while still providing flexibility to encourage innovation that addresses unmet medical needs[.]"

Under section 1143 of the Food and Drug Administration Safety and Innovation Act ("FDASIA"), FDA is required to provide Congress with its notification at least 60 days before issuing the draft or final guidance on the regulation described in that notice.  Therefore, while there is no particular date for the expected guidance, FDA will not issue its guidance until at least October 2014.


1 Defined under 21 C.F.R. 809.3(a) as "those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. These products are devices as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (the act), and may also be biological products subject to section 351 of the Public Health Service Act."

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