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FDA Holds Public Workshop on LDT Draft Guidance

January 9, 2015

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PRESS CONTACTS
Heather Pierce, Sr. Director, Science Policy & Regulatory Counsel
Len Marquez, Senior Director, Government Relations

The Food and Drug Administration (FDA) Jan. 8-9 held a public workshop to discuss the agency’s draft guidance, “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” and “FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs)” issued Oct. 3, 2014.

The workshop highlighted various areas of discussion, including: components of a test and LDT label considerations; clinical validity and intended use; categories for continued enforcement discretion; notification and adverse event reporting (MDRs); public process for classification and prioritization; and quality system regulation.

Stakeholder feedback was provided during several sessions of public comment and included testimony from the University of Colorado, Emory University, Mayo Clinic, Medical College of Virginia at Virginia Commonwealth University School of Medicine, and University of Washington Medical Center, among others.

Comments on the draft guidance are due to the agency by Feb. 2, 2015.

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