Validating high complexity lab test methods

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For example, many LDTs are genetic tests that are developed for rare diseases, such as Huntington disease.

These are diseases that only a small subset of the population has, reducing the incentive for a manufacturer to develop a commercial version because the market for such a product would be small and not offer much, if any, return on investment. Our Industry and Technology, Uses of Diagnostic Tests.

Medical Device Exemptions 510(k) and GMP Requirements.

Available online at https://org/publications/cln/cln-stat/2016/april/21/who-should-regulate-ldts. US Food and Drug Administration: Premarket Approval Applications for In Vitro Diagnostic Devices Pertaining to Hepatitis C Viruses; CDRH Consumer Information, Learn if a Medical Device Has Been Cleared by FDA for Marketing; Device Advice, Class I/II Exemptions.

To access online sources, copy and paste the URL into your browser.

Available online at Devices/Productsand Medical Procedures/Device Approvalsand Clearances/HDEApprovals/

Challenges include developing technical expertise, establishing suitable laboratory facilities, adapting existing quality systems, and laboratory validation of new methods.

This chapter highlights the considerations that should be made prior to setting up these methods and the steps required to achieve accreditation.

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The Public Health Evidence for FDA Oversight of Laboratory Developed Tests: 20 Case Studies Available online at FDA/Reports Manuals Forms/Reports/ucm472773 David Sundwall, formerly President of the American Clinical Laboratory Association.

Available online at https://edu/research/clinical-laboratory-testing.

Available online at https://gov/clia/Resources/Test

Or, an existing test may not apply to a particular subpopulation from which the lab has patients, so modification of the test is required.

(Any FDA-approved commercial test that is modified in any way by a lab is considered to be an LDT and is subject to the regulations applied to all LDTs.) Examples of some LDTs include: In general, because they have not been evaluated by the FDA, LDTs should undergo a more lengthy and rigorous validation process by the individual laboratory wishing to implement the new method.

Director, Center for Devices and Radiological Health, U.

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