Though clinical trials for new medical devices go through specific phases, the process doesn’t follow the traditional I-IV phase structure of drug trials. Steps are less standardized and depend on device-type.
Trial Participants | Trial Endpoints | Regulatory Pathways | Post-Market Surveillance |
|---|---|---|---|
Patients who require the device for diagnosis or treatment as well as healthy volunteers in some cases. | Typically related to device performance, including technical and mechanical reliability as well as clinical endpoints like patient outcomes or quality of life. | Devices are regulated by the F.D.A. or equivalent bodies, but under different guidelines than drugs. Device classification (I, II, or III) dictates the level of regulatory control; pathways are device-specific (e.g., premarket approval or 510(k) clearance in the U.S.). | Monitoring of device safety and performance. |
To assess the safety and performance of new medical devices, which can range from bandages to pacemakers, manufacturers must undertake varying steps or “phases.” Specific phases, requirements, and duration vary by device-type, device complexity, potential risks associated with use, and even region. Regulatory agencies in different countries may have their own processes and requirements for approval. Finally, there’s added complexity based on significant vs. nonsignificant risk devices.
Per the U.S. Food and Drug Administration, a significant risk device presents a potential for serious risk to the health, safety, or welfare of a subject such as implants, devices that support or sustain human life, and devices that are substantially important in diagnosing, curing, mitigating or treating disease or in preventing impairment to human health. Examples include sutures, hydrocephalus shunts, and orthopedic implants.
Nonsignificant risk devices are devices that don’t pose a significant risk to research subjects. Examples include most daily-wear contact lenses and lens solutions, ultrasonic dental scalers, and catheters.
While not officially a phase, preclinical testing is crucial for medical devices. Before human trials, new devices typically undergo extensive laboratory and animal testing to assess safety, functionality, and feasibility.
Researchers and engineers work to identify any potential design flaws, gathering preliminary data on device safety and effectiveness in order to make any adjustment to the device.
Objectives: Evaluate the device design concept with respect to initial clinical safety and functionality as well as inform modifications.
Participants: Small number of subjects are enrolled.
Duration: Varies by device classification and regulator.
Sometimes referred to as “First-in-Human studies,” researchers gather data on medical device safety and effectiveness.
Objectives: Assess device safety, initial efficacy, and functionality in people.
Participants: Small number of carefully selected patients or healthy volunteers.
Duration: Varies by device classification and regulator.
In the U.S., medical device trials often require an IDE from the F.D.A. before moving to human trials. The IDE application includes preclinical data and a proposed clinical trial plan.
Objective: Obtain premarket application approval from regulator(s), or evaluate modifications or new uses of legally marketed devices.
Participants: Varies by device classification and regulator.
Duration: Varies by device classification and regulator.
Researchers gather additional data on how the device interacts with human physiology.
Objective: Further evaluate device safety and initial performance.
Participants: Larger group of patients or healthy volunteers compared to feasibility studies.
Duration: Varies by device classification and regulator.
Pivotal trials may be divided into Phase II-equivalent and Phase III-equivalent studies. Phase II-equivalent studies focus on efficacy and safety in a larger patient population. Phase III-equivalent studies continue to evaluate efficacy, safety, and overall device performance in a larger, more diverse patient population.
Objective: Demonstrate safety and effectiveness to form the basis for regulatory approval.
Participants: A larger number of patients as it’s designed to provide substantial evidence of device safety and efficacy.
Duration: Varies greatly depending on device complexity and intended use.
Data from clinical trials are submitted to regulatory agencies for review and approval. The F.D.A., for example, assesses device safety, effectiveness, and risk-benefit profile before granting market approval.
Objective: Market approval.
Participants: N/A.
Duration: Varies greatly depending on device complexity and intended use.
After market approval, the device continues to be monitored for safety and performance in real-world settings. Adverse events and long-term outcomes are tracked. Any necessary updates to the device or usage guidelines are made based on post-market data.
Objectives: Identify unforeseen issues, assess long-term performance, and ensure the device remains safe and effective.
Focus: Long-term performance and safety.
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