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An Interview With Drs. Meghan Delaney and Eric Konnick: How FDA Restrictions on Laboratory-Developed Tests Will Harm Patients and Increase Costs
The FDA recently announced a plan to regulate laboratory-developed tests (LDTs) as medical devices. In this interview, Dr. Meghan Delaney from Children’s National Hospital and Dr. Eric Konnick from the University of Washington explain why many tests that are critical to patient care, particularly in the areas of pediatrics, transplantation, and rare diseases, may become unavailable if the rule the FDA has proposed is enacted. Other tests may remain available, but at a significantly increased cost. Dr. Jonathan Genzen, ARUP’s chief medical officer and cohost of this episode, describes how laboratory professionals can provide public feedback to the FDA before the rule takes effect.
Related Information:
- Click Here to access the FDA public comment webpage for the newly proposed LDT rule.
- ARUP Joins Industry Partners in Opposing Proposed FDA Rules Seeking to Regulate Laboratory-Developed Tests
- ACLA Opposes Unilateral FDA Action to Regulate Laboratory Developed Tests Under Medical Device Authority
- Laboratory-Developed Tests Account for a Small Minority of Tests Ordered in an Academic Hospital System
- Laboratory-Developed Tests: A Legislative and Regulatory Review
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By ARUP Laboratories
4.9
2929 ratings
The FDA recently announced a plan to regulate laboratory-developed tests (LDTs) as medical devices. In this interview, Dr. Meghan Delaney from Children’s National Hospital and Dr. Eric Konnick from the University of Washington explain why many tests that are critical to patient care, particularly in the areas of pediatrics, transplantation, and rare diseases, may become unavailable if the rule the FDA has proposed is enacted. Other tests may remain available, but at a significantly increased cost. Dr. Jonathan Genzen, ARUP’s chief medical officer and cohost of this episode, describes how laboratory professionals can provide public feedback to the FDA before the rule takes effect.
Related Information:
- Click Here to access the FDA public comment webpage for the newly proposed LDT rule.
- ARUP Joins Industry Partners in Opposing Proposed FDA Rules Seeking to Regulate Laboratory-Developed Tests
- ACLA Opposes Unilateral FDA Action to Regulate Laboratory Developed Tests Under Medical Device Authority
- Laboratory-Developed Tests Account for a Small Minority of Tests Ordered in an Academic Hospital System
- Laboratory-Developed Tests: A Legislative and Regulatory Review
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