How should a new pacemaker that is designed to pose fewer risks be classified?

The classification of a new pacemaker that is designed to pose fewer risks would typically align with the definition of a non-significant risk device. Devices classified this way are those that do not present a meaningful risk of harm to participants in clinical trials.

Understanding the regulatory framework, significant risk devices are those that could pose a greater threat to the health and safety of patients, often leading to stricter oversight. Given that the pacemaker is intended to reduce risks, it aligns more closely with a classification of a non-significant risk device, which allows for less stringent requirements in terms of clinical trials and ethical oversight.

Exempt devices are those that are not subject to the same regulatory controls and are typically low-risk items. High-risk devices would designate a higher level of scrutiny and regulatory requirements due to potential for significant harm. Thus, classifying the new pacemaker as a significant risk device would misrepresent its intended design and the reduced risk it poses.