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Glossary Term
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Non-Significant Risk Device (NSR)

Definition

A Non-Significant Risk Device (NSR) refers to a medical device that is considered to pose minimal risk to the patient and, therefore, does not require the same level of regulatory scrutiny as a Significant Risk Device (SRD). NSR devices are typically subject to less stringent regulatory requirements, such as fewer or no clinical trials, depending on their intended use and the risks they present. These devices may be used for low-risk diagnostic or therapeutic purposes and are generally considered safe for clinical use based on their design and the minimal risk they pose.

Relevance to the MedTech Industry

In the MedTech industry, the classification of a device as NSR ensures that regulatory bodies like the FDA can focus resources on higher-risk devices while still maintaining safety oversight of low-risk devices. By classifying certain devices as NSR, companies can bring useful products to market more quickly and efficiently, without compromising patient safety or efficacy.

Additional Information & Related Terms

Examples of Non-Significant Risk Devices

  1. Orthopedic Braces:

    • A knee brace that is designed to provide support for minor sprains without significant risk to the patient’s health.

  2. Non-Invasive Diagnostic Devices:

    • A blood glucose meter used to measure blood sugar levels that does not involve invasive procedures and poses minimal risk.

  3. Contact Lenses (Non-Therapeutic):

    • Daily wear contact lenses that do not alter the structure or function of the eye and are considered low risk when used as directed.

  4. Bandages or Wound Dressings:

    • Simple wound dressings that are intended to protect a wound from infection without significant risk to the patient.

  5. Thermometers and Pulse Oximeters:

    • Devices used to measure temperature or oxygen levels in the blood, typically non-invasive and with minimal risk of harm.

Related Terms

  • Significant Risk Device (SRD): Devices that are considered to pose a higher risk to the patient and require more extensive clinical trials and regulatory oversight.

  • Investigational Device Exemption (IDE): A regulatory approval process required for high-risk devices (SRDs) to conduct clinical trials. NSR devices are typically exempt from this process.

  • 510(k) Clearance: A regulatory process by which many medical devices are cleared for market use in the U.S. after demonstrating substantial equivalence to an existing device, often applicable to NSR devices.

  • Class I and II Devices: Medical device classifications that generally include low- and moderate-risk devices. NSR devices often fall under these categories, whereas high-risk devices are usually classified as Class III.

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