FDA / CMS Task Force on LDT Quality Requirements Is a Step in the Right Direction

FDA recently announced that FDA and CMS will form a task force to focus on the quality requirements of laboratory developed tests (LDTs). The overall goals of the task force are to clarify the roles of the two agencies and avoid a duplication of efforts.

Last fall, FDA released two draft guidance documents here and here in which FDA would phase in the enforcement of premarket review requirements, FDA notification and MDR requirements, and the quality system regulation requirements for a subset of LDTs. FDA’s goal in overseeing LDTs is to assure that they are analytically and clinically valid. “We intend to clarify the terms used so that labs may better understand what is expected of them,” explained Jeffrey Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health, and Patrick H. Conway, MD, MSc, acting principal deputy administrator CMS Chief Medical Officer.

The goals of the task force also include:

  • To identify areas of similarity between the FDA quality system regulation and requirements under CLIA.
  • To clarify responsibilities for laboratories that fall under the purview of both agencies.
  • To leverage joint resources to maximize efficiency.

The oversight of LDTs is highly sensitive, as it directly affects patient care. The agencies are optimistic that formalized coordination can lead to accurate tests and clinically meaningful outcome information.

A experienced regulatory consultant can help navigate the premarket review and quality system regulation requirements for LTDs.

Trish Landry, MBA, RAC, CCRP
Melissa Barhoover, PhD, RAC

Date posted: April 30, 2015

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