What is purpose of a medical device pre-market notification

Reference no: EM133290428

Assignment:

1. What is the purpose of a medical device Pre-Market Notification (510k)?

a) to obtain authorization to conduct a device trial
b) to obtain marketing authorization for a device
c) to prove that the device is substantially equivalent to a device already on the market
d) to prove that the device has been thoroughly tested in humans via a clinical trial

2. This medical device class includes products that are intended to sustain/support life and/or are devices implanted into the human body:

a) Class I
b) Class II
c) Class III

3. This class of medical device presents minimal potential for harm, and may include products such as band-aids or bandages.

a) Class I
b) Class II
c) Class III

4. ANDA applications are always required to include pre-clinical (animal) and clinical (human) data.

a) True
b) False

5. One of the most significant changes to the recent revision of ICH E6, Good Clinical Practice, includes:

a) Increased IMP management requirements
b) removal of PI oversight requirements
c) implementation of robust risk management processes
d) removal of monitoring requirements

Reference no: EM133290428

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