Glossary Term
Significant Risk Device (SR)
Definition
A Significant Risk Device (SR) is a medical device that, based on its intended use or potential risks, poses a higher level of risk to patient health and safety. These devices typically require more rigorous regulatory scrutiny, such as a premarket approval (PMA) or investigational device exemption (IDE) from regulatory bodies like the FDA. SR devices are subject to more stringent clinical trial requirements due to the potential risks they may pose if they fail or malfunction. The classification of a device as "significant risk" depends on its intended purpose, potential adverse effects, and the clinical setting in which it is used.
Relevance to the MedTech Industry
The classification of a device as significant risk (SR) directly impacts how the device is developed, tested, and regulated. SR devices require thorough clinical investigations to ensure their safety and efficacy, which involves obtaining necessary regulatory approvals and adhering to strict standards. The FDA and other regulatory agencies use this classification to protect patients from unnecessary risks by ensuring that devices with higher potential risks undergo more intensive testing, including clinical trials, and comply with applicable regulatory standards. Understanding whether a device is classified as SR is crucial for manufacturers as it shapes the entire product development process, including regulatory submissions, testing, and market entry.
Additional Information & Related Terms
Examples of SR Device Applications
Implantable Medical Devices:Devices such as pacemakers, cochlear implants, or defibrillators are classified as SR because their failure could result in life-threatening consequences or permanent disability.
Surgical Instruments and Robotics:High-risk surgical instruments, especially robotic surgery systems that assist in performing complex procedures, require significant regulatory oversight due to the risks of malfunction during surgery.
High-Risk Diagnostic Devices:Diagnostic devices that have a direct impact on patient treatment or outcomes, such as imaging systems used for early cancer detection, may be classified as SR due to the potential consequences of incorrect results.
Related Terms
Premarket Approval (PMA): A regulatory pathway required for SR devices, which involves submitting clinical trial data to prove safety and effectiveness before a device can be marketed.
Investigational Device Exemption (IDE): A regulatory approval required to conduct clinical trials on SR devices before they can be submitted for PMA.
Class III Device: Medical devices that carry the highest risk and require premarket approval (PMA). Most SR devices fall under this classification.
Risk Management (ISO 14971): A process used to identify and mitigate risks associated with medical devices, particularly those classified as SR devices.
Clinical Trials: Essential studies conducted to assess the safety, efficacy, and risks of SR devices before they are approved for market use.