ASCP Delegation Meets with FDA on LDT Oversight

ASCP leaders met with officials from the Food and Drug Administration (FDA) on September 26 to discuss reforming the oversight requirements for laboratory developed tests (LDTS). The meeting, a listening session between ASCP leadership and FDA senior officials, touched on a number of the key issues related to the oversight of Laboratory Developed Tests and In Vitro Diagnostics. ASCP and the FDA noted their shared patient-centric concerns of ensuring quality patient testing and access to innovative diagnostics and the need to identify a regulatory standard capable to ensuring both flourish.

FDA officials included Jeff Shuren, MD, JD, Director of the Center for Devices and Radiological Health (CDRH), Timothy Stenzel, MD, PhD, Director of the Office of In Vitro Diagnostics, and Elizabeth Hillebrenner, Associate Director for Scientific and Regulatory Programs and Chief of Staff at CDRH. ASCP representatives at the meeting included ASCP Past President William G. Finn, MD, MASCP, and ASCP Commission on Science, Technology and Policy Chair Gary W. Procop, MD, MS, MASCP, and staff from the ASCP Washington, D.C., office.

Other articles in the October 2019 ePolicy News:

Fix PAMA, Don’t Change Laboratory Date of Service Rule, ASCP Urges CMS
Meaningful Participation Sought Under the QPP for Pathologists in 2020
ASCP Opposes E/M Proposal in Medicare Physician Fee Schedule
CDC Coordinates Investigation, Offers Healthcare Provider Resources Regarding Lung Disease Associated with Vaping
ASCP Expands List of Choosing Wisely Recommendations
Choosing Wisely Champions Recognized for Reducing Unnecessary Testing

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For more information regarding ASCP's advocacy initiatives and policy positions, please contact ASCP's Center for Public Policy at (202) 408-1110.

ASCP ePolicy News is supported by an unrestricted grant from Hologic.