Significant Risk (SR)

What does it mean if a device is a significant risk?

Devices used on human subjects to complete safety and effectiveness investigations are considered “investigational devices,” and are designated as representing a significant risk (SR) or non-significant risk (NSR).

An SR device poses a potentially serious risk to a subject’s welfare, health, and safety. These devices may be:

  • used as an implant
  • used for substantial importance in diagnosing, mitigating, treating, or curing disease
  • purported to support or sustain human life

Examples of SR devices include:

  • Cardiac pacemakers
  • Sutures
  • Orthopedic implants
  • Hydrocephalus shunts

In comparison, NSR devices do not pose a significant risk to patients. They may include ultrasonic dental scalers, day-wear contact lenses, or Foley catheters.

Before being used in a study, SR devices must meet all regulatory requirements in 21 CFR 812, including IRB and FDA approval. In comparison, NSR device studies require only IRB approval. Furthermore, SR devices require submission of an investigational device exemption (IDE) to the Centers for Devices and Radiological Health (CDRH), while NSR devices have abbreviated IDE requirements.

Why are significant risk devices important for healthcare?

Significant risk devices are developed for diagnosing, mitigating, treating, or curing disease or preventing the decline of human health. While they can pose a potential for serious risk to the safety, health, or welfare of the subject, the purpose of clinical studies is to determine if the benefits offered by the SR device outweigh those risks.