Devices used on human subjects to conduct investigations of safety and effectiveness are considered “Investigational Devices” (Section 520(g) of FD&C Act). Significant Risk (SR) device presents a potential for serious risk to the health, safety and welfare of a subject, and
Intended to be used as an implant;
- Or purported to support or sustain human life;
- Or is used for substantial importance in diagnosing, curing, mitigating or treating disease;
- Or otherwise presents a potential for serious risk to the health, safety, or welfare of a subject
Examples of SR devices include sutures, cardiac pacemakers, hydrocephalus shunts, and orthopedic implants. Conversely, non-significant risk (NSR) device studies do not pose a significant risk to patients. Non-significant risk should not be confused with “minimal risk,” a term used by the FDA to classify studies. Examples of NSR devices include most day-wear contact lenses and lens solutions, ultrasonic dental scalers, and foley catheters. SR devices must meet all regulatory requirements set in 21 CFR 812, including the requirement for approval by both IRB and the FDA before commencing the study. Significant risk devices require submission of an investigational device exemption (IDE) to CDRH. NSR device studies may commence without FDA approval, based solely on the IRB approval. However, the sponsor-investigator must follow abbreviated IDE requirements, which are, in essence, the same requirements as regular IDE only without FDA submission (21 CFR 812.2 (b)). The IRB acts as a surrogate overseer for the FDA.
FDA Guidance: Significant Risk and Non-significant Risk Medical Device Studies
The Office for Research Protections Quality Assurance Program can help investigators determine if a device is SR or NSR. Contact them at orp-qm@psu.edu.