PMA in US, and Submit to EU NB Class D

Under EU MDR, how is software that drives or influences a medical device classified?

It inherits the classification of the device it drives or influences

Submit a new Premarket Notification (510(k)) with a PCCP to FDA

Submit a Premarket Notification [510(k)] as a Class II device

What does EU MDR say about translation requirements for medical devices?

translation req.s are set at the national level and may vary based on user

Under EU MDR, which of the following best describes the regulatory treatment of accessories to AIMDs?

They are classified independently based on their own intended purpose

A CER, software lifecycle documentation (IEC 62304), and risk management

Under IEC 62304, which of the following is NOT one of the five main software life cycle processes?

Software Clinical Evaluation Process

Which of the following best describes the FDA’s approach to categorizing SaMDs?

Based on the sig. of the info provided & the seriousness of the condition

Which of the following are least regulated in the US?

Laboratory Developed Tests (LDT)

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Discussion #5

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Answers

1
Question
510(k) notification to the FDA, self-certify under the EU IVDR as a Class A
Register with FDA as a Class I device, CE marking Class B.
PMA in US, and Submit to EU NB Class D
De Novo request to the FDA, EU Class C
2
An implantable nerve simulator, bladder simulators, and cochlear are examples of?
AIMDs
AMDs
IVDs
MRIs
3
Which of the following are not regulated by EU IVDR 2017/746?
Pregnancy Tests
Pulse Oximeters
Specimen receptacles
COVID-19 Tests
4
You develop a diagnostic device to screen for specific protein for lab purposes. What IVDR class is this device?
B
C
D
A
5
The Telesurgery software intended to conduct a surgical procedure from a remote location is an example of:
Information System
Hospital Information System (HIS)
Decision Support Software
Communication Systems
6
The US FDA CBER Regulates and IVD for?
Performance Screening
Self Testing
Near Patient Testing
Blood Donor Screening
7
Under EU MDR, how is software that drives or influences a medical device classified?
It is classified as Class III as high-risk due to influencing the med dev.
It inherits the classification of the device it drives or influences
It is always classified as Class I regardless of the device
It is classified independently of the device it supports
8
Question
Wait until the next AR cycle to include the update in your documentation
Release the update immediately
Notify users via email and update the app without informing the FDA
Submit a new Premarket Notification (510(k)) with a PCCP to FDA
9
Question
Submit a Premarket Approval (PMA) application as a Class III device
Submit a Premarket Notification [510(k)] as a Class II device
No FDA submission is required if the test is used only in a single lab
Register the test as a Class I device with general controls only
10
What does EU MDR say about translation requirements for medical devices?
only implant cards and field safety notices require translations
translation req.s are set at the national level and may vary based on user
All info must be in all 24 EU languages, regardless of the device type/user
Only English is required as it's the EU's official working language
11
A standalone mobile app analyzes heart rate trends and gives alerts for potential arrhythmias-what class is it under MDR
Class III
Class I
Class IIb
Class IIa
12
Under EU MDR, which of the following best describes the regulatory treatment of accessories to AIMDs?
Accessories are exempt from classification if used exclusively with AIMDs
They are classified independently based on their own intended purpose
Accessories inherit the classification of the AIMD they support
Accessories are always classified as Class IIb regardless of function
13
An AIMD, under normal use, cannot have a surface temp. higher than the average body temperature by how many degrees:
2.5oC
2oC
1oC
1.5oC
14
Question
A declaration of conformity and a marketing plan
A CER, software lifecycle documentation (IEC 62304), and risk management
A usability engineering file and a cybersecurity penetration test report
A CE cert from a previous MDD approval and a GDPR compliance checklist
15
Under IEC 62304, which of the following is NOT one of the five main software life cycle processes?
Software Maintenance Process
Software Development Process
Software Configuration Management Process
Software Clinical Evaluation Process
16
Which of the following best describes the FDA’s approach to categorizing SaMDs?
Based on the sig. of the info provided & the seriousness of the condition
According to the device’s class under the PMA or 510(k) pathway
Based on the device’s hardware complexity and software architecture
According to the SaMD’s intended use and the manufacturer’s market strategy
17
AIMDs are outside the scope of which standard?
ISO 10993
ISO 11607
IEC 60601
EN 45502-1
18
Which of the following are least regulated in the US?
Laboratory Developed Tests (LDT)
IDE
De Novo
Companion Diagnostic Devices (CDx)
19
In Australia, AIMDs are classified as:
Class IV
Class AIMD
Class 4
Class III
20
Question
Class D
Class A
Class C
Class B

Discussion #5 Flashcards | StudBud