Clinical Evaluation
Clinical Investigations Consult with FormlyAI
Receive expert guidance determining clinical study needs and designing efficient investigation protocols.
Summary
A clinical investigations consult provides expert guidance on whether your medical device requires clinical studies and how to design appropriate clinical investigation protocols. This consultation helps determine if literature-based clinical evaluation is sufficient or if you need to conduct clinical trials to demonstrate safety and clinical performance.Why is Clinical Investigations Consult important?
Clinical investigations represent a significant investment in time, resources, and regulatory complexity that many medical device companies want to avoid if possible. However, certain devices cannot achieve market approval without clinical study data, particularly novel technologies, high-risk devices, or those lacking adequate equivalent devices. A clinical investigations consult helps you make informed decisions about whether clinical studies are necessary for your specific device and regulatory pathway. This consultation can save substantial costs by identifying alternative evidence strategies or ensuring you design efficient studies that meet regulatory requirements. Without proper guidance, you risk conducting unnecessary studies or designing inadequate protocols that don’t support regulatory approval.Regulatory Context
Under 21 CFR Part 812 (Investigational Device Exemptions):
- Significant risk devices require FDA IDE approval before clinical studies
- Non-significant risk devices may proceed with IRB approval only
- 510(k) pathway typically relies on predicate device comparison rather than clinical studies
- De Novo pathway for novel devices often requires clinical data
Special attention required for:
- Class III devices requiring PMA with clinical trial data
- Software medical devices with AI/ML algorithms requiring real-world validation
- Novel devices without adequate predicate devices
- Devices with new indications for use requiring clinical validation
Guide
A clinical investigations consult systematically evaluates your device’s clinical evidence needs and determines the most efficient pathway to regulatory approval. The consultation process helps optimize your clinical development strategy while minimizing unnecessary costs and delays.Device Assessment and Classification
The consultation begins with comprehensive device characterization including intended use, patient population, risk classification, and regulatory pathway. Your device’s novelty, complexity, and risk profile directly influence clinical investigation requirements. Software medical devices, particularly those with AI/ML components, may require clinical validation even at lower risk classifications.Regulatory Pathway Analysis
Different regulatory pathways have varying clinical evidence requirements. The 510(k) pathway typically relies on predicate device comparison and literature review, while PMA requires extensive clinical data. De Novo submissions for novel devices often need clinical studies to establish safety and effectiveness. The consultation evaluates which pathway best suits your device and evidence availability.Equivalent Device Analysis
A critical assessment determines whether adequate equivalent devices exist for your intended use. If suitable equivalent devices are available and you can demonstrate technical, biological, and clinical equivalence, clinical investigations may not be necessary. The consultation evaluates potential equivalent devices and assesses the strength of equivalence claims.Literature and State-of-the-Art Review
The consultation examines available clinical literature and state-of-the-art analysis to determine if existing evidence supports your device’s safety and performance claims. Comprehensive literature may provide sufficient evidence for lower-risk devices, while novel applications or limited literature may necessitate clinical studies.Risk-Benefit Assessment
A thorough risk analysis evaluates whether your device’s risks can be adequately characterized through non-clinical testing or require clinical validation. High-risk devices, those with novel mechanisms of action, or devices targeting vulnerable populations typically require clinical investigation data.Clinical Study Design Recommendations
If clinical investigations are necessary, the consultation provides study design guidance including primary endpoints, patient populations, sample size considerations, and regulatory submission strategies. The goal is designing efficient studies that provide adequate evidence while minimizing time and cost.Alternative Evidence Strategies
The consultation explores alternative evidence approaches such as real-world evidence collection, registry studies, or post-market clinical follow-up that might satisfy regulatory requirements without traditional clinical trials. These approaches can be particularly valuable for software devices or those with existing clinical use.Regulatory Submission Strategy
The consultation develops a comprehensive regulatory strategy integrating clinical evidence with other submission components. This includes timing recommendations, regulatory meeting strategies, and coordination with quality system and technical documentation requirements.Example
Scenario: You’ve developed an AI-powered diagnostic software that analyzes medical images to detect early-stage skin cancer. The software is classified as Class IIb and you’re considering both FDA 510(k) and EU MDR pathways. You need guidance on whether clinical investigations are required.Clinical Investigations Consult Process
1. Device Assessment- Device: DermAI Pro v2.0, AI-powered skin cancer detection software
- Classification: Class IIb (EU), Class II (US)
- Intended use: Assist dermatologists in early skin cancer detection
- Patient population: Adults with suspicious skin lesions
- Novel aspects: Proprietary AI algorithm, enhanced detection accuracy claims
- FDA pathway: 510(k) with predicate device comparison
- EU pathway: CE marking under MDR with clinical evaluation
- Key challenge: AI algorithm requires performance validation
- Recommendation: Pursue 510(k) first, then leverage data for EU submission
- Identified predicates: 3 FDA-cleared skin imaging devices
- Limitations: Different AI algorithms, varying performance claims
- Equivalence assessment: Technical similarities exist, but clinical performance differs
- Conclusion: Equivalence claims may be challenging due to AI algorithm differences
- FDA: Clinical validation study likely required for AI algorithm performance
- EU: Literature review plus clinical performance study recommended
- Evidence gaps: Real-world diagnostic accuracy, user interface validation
- Alternative: Real-world evidence collection from existing clinical use
- Study type: Prospective, multi-center diagnostic accuracy study
- Primary endpoint: Sensitivity and specificity vs. histopathology gold standard
- Sample size: 500 lesions (based on power analysis for 90% sensitivity)
- Duration: 12 months enrollment, 6 months follow-up
- Sites: 5 dermatology clinics with varying patient populations
- Phase 1: Retrospective analysis of existing image database (n=2,000)
- Phase 2: Prospective validation study (n=500) if retrospective shows promise
- Real-world evidence: Partner with dermatology practices for ongoing data collection
- Post-market: PMCF study for EU requirements and 510(k) special controls
- Pre-submission meeting with FDA to discuss study design
- EU consultation with notified body on clinical evidence requirements
- Parallel development: Conduct studies to satisfy both FDA and EU requirements
- Timeline: 18 months for clinical studies, 6 months for regulatory review
- Clinical study costs: 1,200,000
- Alternative approaches: 400,000 for retrospective analysis
- Market opportunity: $50M annually, justifying clinical investment
- Recommendation: Proceed with clinical studies for optimal market access
Q&A
How do I know if my device needs clinical investigations?
How do I know if my device needs clinical investigations?
Clinical investigation requirements depend on your device’s risk classification, novelty, and available equivalent devices. Class III and some Class IIb devices typically require clinical studies. Novel devices without adequate predicates often need clinical data. Software devices with AI/ML components may require clinical validation regardless of classification. A clinical investigations consult evaluates these factors for your specific device.
Can I avoid clinical studies by using literature review and equivalent devices?
Can I avoid clinical studies by using literature review and equivalent devices?
Yes, if adequate equivalent devices exist and you can demonstrate technical, biological, and clinical equivalence. Literature-based clinical evaluation is often sufficient for Class I and IIa devices with established equivalent devices. However, novel technologies, AI algorithms, or devices with new indications typically require clinical validation even with equivalent devices available.
What's the difference between significant risk and non-significant risk device studies?
What's the difference between significant risk and non-significant risk device studies?
Significant risk devices require FDA IDE approval before starting clinical studies, while non-significant risk devices can proceed with IRB approval only. The determination depends on factors like invasiveness, implantation, life support use, and potential for serious harm. Most software medical devices are considered non-significant risk, but AI diagnostic devices may be classified as significant risk.
How long do clinical investigations typically take?
How long do clinical investigations typically take?
Timeline varies significantly based on study design, patient population, and endpoints. Simple usability studies may take 3-6 months, while diagnostic accuracy studies typically require 12-18 months. Long-term safety studies for implantable devices can take 2-5 years. Early consultation helps optimize study design to minimize duration while meeting regulatory requirements.
What are the alternatives to traditional clinical trials?
What are the alternatives to traditional clinical trials?
Alternatives include real-world evidence collection, registry studies, retrospective database analyses, and post-market clinical follow-up studies. These approaches can be particularly valuable for software devices or those with existing clinical use. However, regulatory acceptance varies by device type and jurisdiction, requiring careful strategy development.
How much do clinical investigations typically cost?
How much do clinical investigations typically cost?
Costs vary widely based on study complexity, duration, and patient population. Simple usability studies may cost 150,000, while multi-center diagnostic studies can cost 2,000,000. Pivotal trials for high-risk devices may exceed $5,000,000. Early consultation helps optimize study design to control costs while meeting regulatory requirements.