The definition of A Significant Risk (SR),is a device presents a potential for serious risk of health, safety and welfare of a subject, and are intended to be used as an implant and; purported to support or sustain human life; and is used for substantial importance in diagnosing, curing, mitigating, or treating disease. Examples of SR devices include sutures, cardiac pacemakers, hydrocephalus shunts, and orthopedic implants.SR devices must meet all regulatory requirements in 21 CFR 812, including the requirement for approval by both IRB and the FDA before beginning the study. SR studies requires high intensity monitoring.
Non-significant risk (NSR) device studies do not pose a significant risk to patients. Non-significant risk should not be confused with “minimal risk”. Examples of NSR devices include most day-wear contact lenses and lens solutions, and tongue depressor.