Medical Device Enforcement Discretion

FDLI Enforcement, Litigation and Compliance Conference December 8, 2014 Linda D. Bentley

Laboratory Developed Tests (LDTs) • • IVD test validated and performed in a single CLIA certified clinical laboratory Generally not subject to premarket review and other FDA requirements.

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Proposed LDT Regulatory Oversight Framework • • – Notice to Congress 7/13/14 Required by FDASIA Posting of draft guidance 10/13/14 – – 120-day comment period See guidance at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Guidance Documents/UCM416685.pdf

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Companion Diagnostics • • A medical device (often IVD) that provides information essential for safe and effective use of a corresponding drug Guidance issued on 8/6/14 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDo cuments/UCM262327.pdf

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Thank you!

Linda D. Bentley [email protected]

617-348-1784

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