Respuesta :
I believe the answer is: Significant risk device
A device would be considered to have a 'significant risk' if that device present a potential serious threat for the users' health or welfare in general. Such status is determined by the Institutional review board before deciding whether the device is allowed to be sold to the public or not.
Answer:
The introduction of a new pacemaker in the market should be recognized as a significant risk device.
Explanation:
The new pacemaker against the competition of the existing commercially viable pacemaker device should be viewed as a significant risk. Pacemaker is a medical device that can directly affect human health and thus it has to be significantly investigated by the sponsors.
Further Explanation:
The determination of whether the device is ‘significantly risky’ or ‘non - significantly risky’ is decided by the Food and Drug Administration. The pacemaker is a medical instrument that generates electrical impulses to contract the muscles of the heart and regulate the functioning of the heart. Keeping this in mind, the pacemaker is given the attribution of being significantly risky. This is because the pacemaker can do serious harm to its subjects, it thus, tends to decide the life of a patient. Thus even the modern day pacemakers may be believed to be less dangerous than compared to the commercially available pacemakers in the market, the pacemaker has been adjudged to contain significant risk.
Learn More:
- Functions of a pacemaker, https://brainly.com/question/10393409, Answered by Theresemarie
- Role of FDA, https://brainly.com/question/2026177 , Answered by Taskmasters
Keywords:
Pacemakers, FDA, significant risks associated with pacemakers, medical risk devices, determination of risks of medical devices, significant risk device.
