Transcript FDA’s Draft LDT Framework & Personalized Medicine Update

FDA’s Draft LDT Framework
&
Personalized Medicine Update
Elizabeth Mansfield, PhD
OIR/CDRH/FDA
ACLA
May 5, 2015
Proposed Framework for LDT
Oversight
• Two draft guidance documents:
– Draft Guidance for Industry, Food and Drug Administration Staff,
and Clinical Laboratories: Framework for Regulatory Oversight
of Laboratory Developed Tests (LDTs)
– Draft Guidance for Industry, Food and Drug Administration Staff,
and Clinical Laboratories: FDA Notification and Medical Device
Reporting for Laboratory Developed Tests (LDTs))
• Published October 3, 2014
• Public meeting January 2015
• Comment period closed March 2015
Basic Overview
• FDA proposed oversight of LDTs:
– Risk-based
– Phased-in
– Premarket review, QS for most LDTs
– Requirement for “notification” for all LDTs
– Requirement for adverse event reporting for
all LDTs
“Carve-outs”
• Continued enforcement discretion for:
– Rare tests
– Tests for unmet need
– Traditional LDTs
– Forensic (Law Enforcement) LDTs
– LDTs Used in CLIA-Certified, HighComplexity Histocompatibility Laboratories for
Transplantation
• Intent: preserve access, promote
innovation
Notification
• All labs notify who they are and what LDTs
they offer—6 months (or register and list)
• FDA uses notification to inform
classification panels for new intended uses
• Highest risk LDTs identified in draft
Framework
Highest Risk
Regulatory Oversight Phase-in:
a) LDTs with the same intended use as a cleared or approved companion
diagnostic
b) LDTs with the same intended use as an FDA-approved Class III medical
device; and
c) certain LDTs for determining the safety or efficacy of
blood or blood products.
Other high risk devices:
a) Screening devices for serious diseases and/or conditions intended for use in
asymptomatic patients with no other available confirmatory diagnostic product or
procedure, such as screening device for malignant cancers
(b Diagnostic devices for certain infectious diseases with high-risk intended
uses
c) Devices that act like companion diagnostic devices
Classification
• New intended uses classified through
recommendation of advisory panels
– Several panels
– Draft guidance issues 24 with classifications
for all tests
– Already classified tests use existing
classification
Phase-In Schedule
• 9 year phase-in
• Highest risk first
• Work through risk categories until
complete
• Categories called in by announcement in
advance of requirement to submit
Comments
•
•
•
•
About 300 different commenters
About 1400 different comments
All comments categorized and assessed
Guidances to be revised to reflect FDA’s
consideration of comments
Personalized Medicine
• Personalized Medicine Staff
– 5 FTEs with different types of experience
– Several additional FTEs may be added
– Projects/Guidance documents include:
•
•
•
•
Companion Dx
Investigation Use Device
LDT
NGS, etc
Precision Medicine Initiative
• FDA to create regulatory pathway
appropriate for NGS
– $10M proposed
– Addresses data analytics, informatics, and
regulatory quality databases
– Will be interacting with stakeholders,
publishing draft guidance documents etc
– Stay tuned, its exciting!