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Washington Highlights

FDA Holds Public Workshop on LDT Draft Guidance

January 9, 2015—The Food and Drug Administration (FDA) Jan. 8-9 held a public workshop to discuss the agency’s draft guidance, “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” and “FDA Notification and Medical Device Reporting for Laboratory Developed Tests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Comments on the draft guidance are due to the agency by Feb. 2, 2015.


Heather Pierce, JD, MPH
Sr. Director, Science Policy & Regulatory Counsel
Telephone: 202-478-9926

Len Marquez
Director, Government Relations
Telephone: 202-862-6281


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Washington Highlights, a weekly electronic newsletter, features brief updates on the latest legislative and regulatory activities affecting medical schools and teaching hospitals.

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Jason Kleinman
Sr. Legislative Analyst, Govt. Relations
Telephone: 202-903-0806