Medical Device Report (MDR) Handling

1.

Which circumstances are considered a Reportable Event to the FDA? (Select all that apply)

A.

May have caused or contributed to a death or serious injury
B.

Malfunctions not likely to result in death or serious injury
C.

Malfunctions of the device, or similar device marketed by the manufacturer or importer would be likely to cause death or serious injury if the malfunction were to recur
D.

A product review of one of our devices is found posted on social media

Correct Answer(s)
A. May have caused or contributed to a death or serious injury
C. Malfunctions of the device, or similar device marketed by the manufacturer or importer would be likely to cause death or serious injury if the malfunction were to recur

Explanation
A reportable event to the FDA includes circumstances that may have caused or contributed to a death or serious injury, as well as malfunctions of the device or similar devices marketed by the manufacturer or importer that would be likely to cause death or serious injury if the malfunction were to recur. The option "Malfunctions not likely to result in death or serious injury" is not considered a reportable event because it does not meet the criteria for causing or contributing to death or serious injury. The option "A product review of one of our devices is found posted on social media" is unrelated to reportable events to the FDA and therefore not applicable.

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2.

There are strict time frames that Regulatory must consider when reporting adverse events.

A.

True
B.

False

Correct Answer
A. True

Explanation
Regulatory departments are responsible for ensuring that adverse events related to products or services are reported accurately and in a timely manner. This is crucial for the safety of consumers and compliance with regulations. The strict time frames imposed on regulatory departments help to ensure that adverse events are promptly identified, investigated, and reported to the appropriate authorities. Failing to adhere to these time frames can result in serious consequences, such as fines or legal actions. Therefore, it is important for regulatory departments to prioritize and meet these time frames when reporting adverse events.

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3.

What are the three main factors that Regulatory must consider regarding the reporting of trends?

A.

The number of devices on the market
B.

Reportable Incidents
C.

Incidents that are typically exempt from reporting
D.

Events that are not considered reportable

Correct Answer(s)
B. Reportable Incidents
C. Incidents that are typically exempt from reporting
D. Events that are not considered reportable

Explanation
Regulatory must consider three main factors when it comes to reporting trends. The first factor is reportable incidents, which are incidents that must be reported to the appropriate regulatory authorities. The second factor is incidents that are typically exempt from reporting, meaning that they do not need to be reported. Finally, regulatory must also consider events that are not considered reportable, which are events that do not meet the criteria for reporting. These three factors help regulatory determine which incidents and events need to be reported and which ones do not.

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4.

Which countries do we have to take into consideration when thinking about Medical Device Reporting? (Select all that apply)

A.

United States of America
B.

Canada
C.

Australia
D.

European Economic Area, including Switzerland and Turkey
E.

New Zealand

Correct Answer(s)
A. United States of America
B. Canada
C. Australia
D. European Economic Area, including Switzerland and Turkey
E. New Zealand

Explanation
When thinking about Medical Device Reporting, we need to take into consideration the United States of America, Canada, Australia, European Economic Area (including Switzerland and Turkey), and New Zealand. These countries have specific regulations and requirements for reporting medical device incidents and adverse events. It is important to comply with these regulations to ensure patient safety and to meet legal obligations in these jurisdictions.

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5.

In Canada, what is the maximum time frame to submit a report a death, or serious deterioration in the health of patient, user, or other person for an incident?

A.

Within 30 days of becoming aware of the event
B.

Within 48 hours of becoming aware of the event
C.

Within 10 calendar days of becoming aware of the event
D.

Within 7 calendar days of becoming aware of the event

Correct Answer
C. Within 10 calendar days of becoming aware of the event

Explanation
The correct answer is within 10 calendar days of becoming aware of the event. This means that if a death or serious deterioration in the health of a patient, user, or other person occurs, it must be reported within 10 calendar days of becoming aware of the event in Canada.

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Medical Device Report (Mdr) Handling

Which circumstances are considered a Reportable Event to the FDA? (Select all that apply)

There are strict time frames that Regulatory must consider when reporting adverse events.

What are the three main factors that Regulatory must consider regarding the reporting of trends?

Which countries do we have to take into consideration when thinking about Medical Device Reporting? (Select all that apply)

In Canada, what is the maximum time frame to submit a report a death, or serious deterioration in the health of patient, user, or other person for an incident?