As CLN Stat previously reported, since the U.S. Food and Drug Administration (FDA) published draft guidance in October 2014 outlining plans for regulating laboratory developed tests (LDTs), various stakeholders have expressed concerns about the agency’s proposed approach. An upcoming AACC webinar, “The Future of LDT Oversight,” aims to clarify what the new developments could mean for oversight of LDTs.
“I will be discussing how the regulations could impact your laboratory,” James Nichols, PhD, director of clinical chemistry at the Vanderbilt University School of Medicine in Nashville, Tennessee, told CLN Stat. Nichols, who also chairs AACC’s Government Relations Committee, will co-host the webinar along with Peter Kazon, JD, senior counsel at Alston & Bird in Washington, DC.
“The presentation will define LDTs, give a brief history of FDA oversight and enforcement discretion, describe the proposed changes to LDT enforcement, and discuss several concerns for impact on clinical laboratory operations,” Nichols explained.
The proposed oversight “could have benefits from the FDA independent premarket review, clinical validation and postmarket surveillance processes,” which current LDTs are not subjected to, he explained. “However, additional oversight could have unforeseen consequences such as increasing cost, delays in offering new tests, and disruption of lab director-physician partnership and communication.”
The proposed oversight is not final and could still undergo changes before implementation. “A number of public comments were submitted in response to the release of the FDA’s proposed LDT changes,” Nichols said. “Those comments need to be resolved and a workable solution developed that will both ensure safety and quality performance of LDTs amongst different laboratories, but also not delay the release or prohibit the development of new LDTs.”
The 60-minute webinar will be held April 22 at 2 p.m. It is $179 for members and $225 for non-members.