D219- WGU: SCHOLARSHIP IN
NURSING PRACTICE- CITI- FDA-
REGULATED RESEARCH QUESTIONS
AND ANSWERS WITH CORRECT!!!
Medical Device Classification & Risk Assessment
Scenario: A research sponsor intends to test a reengineered version of a standard,
commercially available pacemaker. The goal is to determine if this new iteration
reduces patient risk compared to existing models. Based on its function and
potential impact on a subject, how should this device be categorized for study
purposes?
Answer: Significant risk device ✔️✔️
Criteria for Classification: A device is labeled as a Significant Risk (SR) if it
poses a potential threat to the health, safety, or general welfare of a participant and
meets any of the following conditions:
Human Implantation: The device is designed to be surgically placed inside
a human body.
Life Support: It is essential for sustaining or supporting human life.
Critical Health Function: It plays a major role in the diagnosis, treatment,
mitigation, or prevention of disease and health impairments.
General Risk: It otherwise presents a high probability of serious risk to the
participant's well-being. ✔️✔️
An adult with attention deficit hyperactivity disorder (ADHD) presents to a
physician. To date, no behavioral or drug interventions have proven useful. The
physician has just read several reports about a drug that is approved and marketed
for another indication, but has shown some benefit for ADHD. The physician
wants to prescribe this drug, in the labeled marketed dose, for the individual
patient. Which of the following would be the most appropriate course of action? -
NURSING PRACTICE- CITI- FDA-
REGULATED RESEARCH QUESTIONS
AND ANSWERS WITH CORRECT!!!
Medical Device Classification & Risk Assessment
Scenario: A research sponsor intends to test a reengineered version of a standard,
commercially available pacemaker. The goal is to determine if this new iteration
reduces patient risk compared to existing models. Based on its function and
potential impact on a subject, how should this device be categorized for study
purposes?
Answer: Significant risk device ✔️✔️
Criteria for Classification: A device is labeled as a Significant Risk (SR) if it
poses a potential threat to the health, safety, or general welfare of a participant and
meets any of the following conditions:
Human Implantation: The device is designed to be surgically placed inside
a human body.
Life Support: It is essential for sustaining or supporting human life.
Critical Health Function: It plays a major role in the diagnosis, treatment,
mitigation, or prevention of disease and health impairments.
General Risk: It otherwise presents a high probability of serious risk to the
participant's well-being. ✔️✔️
An adult with attention deficit hyperactivity disorder (ADHD) presents to a
physician. To date, no behavioral or drug interventions have proven useful. The
physician has just read several reports about a drug that is approved and marketed
for another indication, but has shown some benefit for ADHD. The physician
wants to prescribe this drug, in the labeled marketed dose, for the individual
patient. Which of the following would be the most appropriate course of action? -
