Transcript Medical Device Enforcement Discretion

Medical Device Enforcement Discretion
FDLI Enforcement, Litigation and Compliance Conference
December 8, 2014
Linda D. Bentley
Laboratory Developed Tests (LDTs)
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IVD test validated and performed in a single CLIAcertified clinical laboratory
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Generally not subject to premarket review and other FDA
requirements.
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Proposed LDT Regulatory Oversight Framework
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Notice to Congress 7/13/14
– Required by FDASIA
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Posting of draft guidance 10/13/14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
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A medical device (often IVD) that provides information
essential for safe and effective use of a corresponding
drug
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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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