Point-Counterpoint: The FDA Has a Role in Regulation of Laboratory-Developed Tests

Journal of Clinical Microbiology
Angela M Caliendo, Kimberly E Hanson

Abstract

Since the Food and Drug Administration (FDA) released its draft guidance on the regulation of laboratory-developed tests (LDTs) in October 2014, there has been a flurry of responses from commercial and hospital-based laboratory directors, clinicians, professional organizations, and diagnostic companies. The FDA defines an LDT as an "in vitrodiagnostic device that is intended for clinical use and is designed, manufactured, and used within a single laboratory." The draft guidance outlines a risk-based approach, with oversight of high-risk and moderate-risk tests being phased in over 9 years. High-risk tests would be regulated first and require premarket approval. Subsequently, moderate-risk tests would require a 510(k) premarket submission to the FDA and low-risk tests would need only to be registered. Oversight discretion would be exercised for LDTs focused on rare diseases (defined as fewer than 4,000 tests, not cases, per year nationally) and unmet clinical needs (defined as those tests for which there is no alternative FDA-cleared or -approved test). There was an open comment period followed by a public hearing in early January of 2015, and we are currently awaiting the final decision regarding the regulation of LDTs. Given t...Continue Reading

References

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Citations

Dec 14, 2018·Clinical Microbiology Reviews·Carmen L CharltonSteven J Drews
Jul 14, 2020·Current Opinion in Infectious Diseases·Andrew E ClarkFrancesca M Lee
Jan 7, 2017·Modern Pathology : an Official Journal of the United States and Canadian Academy of Pathology, Inc·Jennifer L Hunt
Feb 8, 2018·Annual Review of Medicine·Ephraim L TsalikVance G Fowler
Oct 20, 2018·Nature Reviews. Microbiology·Alex van BelkumUNKNOWN JPIAMR AMR-RDT Working Group on Antimicrobial Resistance and Rapid Diagnostic Testing
Dec 5, 2018·Nature Communications·Brian L Wickes, Nathan P Wiederhold

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