What We Monitor for Diagnostics & IVD Companies
510(k)/De Novo/PMA for IVDs
LDT oversight evolution
CLIA waiver requirements
Companion diagnostic guidance
Emergency use authorization
Performance standards updates
Quality system (QSR) requirements
Analytical validation expectations
Clinical evidence standards
Decisions This Intelligence Affects
Regulatory Strategy
- • Pathway selection (510(k)/De Novo/PMA)
- • Predicate device identification
- • Pre-submission meeting planning
- • CLIA waiver application strategy
Quality & Validation
- • Analytical performance validation
- • Clinical study design requirements
- • Quality system compliance
- • Post-market surveillance obligations
Legal & Compliance
- • LDT regulatory exposure assessment
- • Enforcement discretion interpretation
- • Labeling and claims compliance
- • Reimbursement pathway alignment
Executive Leadership
- • Product launch timeline risk
- • Portfolio regulatory exposure
- • M&A due diligence intelligence
- • Investor and board communications
How Diagnostics Teams Use This Intelligence
Navigate LDT Oversight Changes
Understand evolving FDA authority over laboratory-developed tests
Optimize IVD Submissions
Track 510(k) and De Novo pathway expectations
Accelerate CLIA Waiver Strategy
Align waiver applications with current FDA thinking
Monitor Companion Dx Requirements
Stay ahead of therapeutic pairing guidance
Brief Stakeholders Confidently
Cite regulatory intelligence in investor and board discussions
Support Clinical Study Design
Align validation studies with FDA performance expectations