• Center on Health Equity and Access
  • Clinical
  • Health Care Cost
  • Health Care Delivery
  • Insurance
  • Policy
  • Technology
  • Value-Based Care

Segment 4: The FDA Takes Initiative to Regulate the Diagnostic Test Market

Article

Daniel F. Hayes, MD, discusses the FDA's announcement that it will begin to regulate laboratory-developed tests and his belief that it will not squash innovation in the field.

John Fox, MD, MHA, wondered if the FDA’s announcement that it will begin to regulate laboratory-developed tests being marketed will limit the number of people who develop tests and help clean up the market.

Daniel F. Hayes, MD, hopes that will be the case and he is happy with the FDA initiative and how responsibly the agency has approached beginning to regulate the field.

“There’s a great deal of concern that this will squash innovation and dampen down new test development,” he said. “I think it might have the opposite [effect].”

Related Videos
Mila Felder, MD, FACEP
Kiana Mehring, MBA, director of strategic partnerships, managed care at Florida Cancer Specialists & Research Institute (FCS)
Miriam J. Atkins, MD, FACP, president of the Community Oncology Alliance (COA) and physician and partner of AO Multispecialty Clinic in Augusta, Georgia.
Dr Lucy Langer
Edward Arrowsmith, MD, MPH
Dr Kathi Mooney
Tiago Biachi de Castria, MD, PhD, Moffitt Cancer Center
Related Content
© 2024 MJH Life Sciences
AJMC®
All rights reserved.