For medical device companies, navigating the Investigational Device Exemption (IDE) submission process is a critical step toward clinical trials in the United States. A key consideration during IDE submissions is determining whether a device is classified as Significant Risk (SR) or Non-Significant Risk (NSR). Accurate risk classification influences regulatory requirements, submission pathways, and timelines.
At BioBoston Consulting, we provide expert guidance to help medical device sponsors classify devices correctly and streamline IDE submissions, ensuring compliance with FDA regulations and efficient clinical development.
Understanding Significant vs. Non-Significant Risk Devices
The FDA defines Significant Risk (SR) devices as those that:
- Support or sustain human life
- Present a potential for serious risk to the health, safety, or welfare of a patient
- Are implanted or substantially invasive
Non-Significant Risk (NSR) devices are those that do not meet the criteria for SR classification and typically pose minimal risk to study subjects.
Correctly classifying your device is essential because it determines:
- The need for FDA approval of an IDE before starting clinical trials
- The type of regulatory oversight and review required
- Documentation and submission requirements
Key Considerations in Risk Determination
When evaluating device risk for IDE submissions, companies should consider:
- Intended Use and Clinical Application
Devices designed for critical functions such as life support, implantation, or high-risk diagnostics are often classified as Significant Risk.
- Invasiveness
The level of invasiveness—implantable, surgically invasive, or non-invasive—directly affects risk classification.
- Potential for Harm
Assess the likelihood and severity of potential adverse events. Devices that could cause serious injury or compromise patient safety are considered SR devices.
- Regulatory Guidance
Reference FDA guidance documents, predicate device classifications, and prior approvals to determine the appropriate risk category.
Regulatory Pathways for SR and NSR Devices
- Significant Risk Devices: Require formal IDE submission and FDA approval before initiating clinical trials. The IDE submission must include:
- Preclinical data
- Device description and specifications
- Clinical protocol
- Risk analysis and mitigation plans
- Non-Significant Risk Devices: May proceed with clinical trials under Institutional Review Board (IRB) approval only, often without a full IDE submission. Documentation should still demonstrate safety and compliance with applicable regulations.
Best Practices for IDE Risk Classification
To ensure accurate classification and smooth IDE submission:
- Conduct a thorough risk assessment with cross-functional teams
- Document the rationale for SR or NSR determination
- Review FDA guidance and precedent device classifications
- Engage with regulatory experts early to avoid delays
- Maintain traceable records to support IRB or FDA review
How BioBoston Consulting Supports IDE Submissions
At BioBoston Consulting, we help device sponsors navigate the complexities of IDE risk classification and submission:
- Performing device risk assessments to determine SR vs. NSR status
- Preparing compliant IDE submission packages for FDA approval
- Advising on preclinical testing strategies to support risk classification
- Ensuring proper documentation for IRB or FDA review
- Supporting regulatory strategy and project timelines for clinical trials
Our expert guidance minimizes delays, mitigates compliance risks, and accelerates clinical development.
Partner with BioBoston Consulting for IDE Success
Accurate determination of Significant vs. Non-Significant Risk devices is critical to achieving timely FDA approval and successful clinical trials. A proactive approach ensures compliance, reduces regulatory risk, and streamlines development pathways.
👉 Partner with BioBoston Consulting today to classify your medical devices correctly and prepare robust IDE submissions.
Contact BioBoston Consulting to ensure your IDE submissions are accurate, compliant, and ready for FDA review.