1. FDA’s Draft LDT Framework & Personalized Medicine Update
Elizabeth Mansfield, PhD
OIR/CDRH/FDA
ACLA
May 5, 2015

2. 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Two draft guidance documents:
Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories: Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)
Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories: FDA Notification and Medical Device Reporting for Laboratory Developed Tests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

3. 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

4. “Carve-outs” Continued enforcement discretion for:
Rare tests
Tests for unmet need
Traditional LDTs
Forensic (Law Enforcement) LDTs
LDTs Used in CLIA-Certified, High- Complexity Histocompatibility Laboratories for Transplantation
Intent: preserve access, promote innovation

5. 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

6. Highest Risk Regulatory Oversight Phase-in: Other high risk devices:
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

7. 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Draft guidance issues 24 with classifications for all tests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

8. 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

9. 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

10. 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

11. 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!