Medical Device Enforcement Discretion

download report

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

2

Proposed LDT Regulatory Oversight Framework • • – Notice to Congress 7/13/14 Required by FDASIA Posting of draft guidance 10/13/14 – – 120-day comment period See guidance at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Guidance Documents/UCM416685.pdf

3

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

4

Thank you!

Linda D. Bentley [email protected]

617-348-1784

5