Medical Device Licensing Flashcards
1
Q
Active Device
A
Depends on a source of energy for operation other than energy from human body or gravity.
2
Q
Active Diagnostic Device
A
Supplies information to detect, monitor or treat physiological condition.
3
Q
Active Therapeutic Device
A
Support, modify, replace or restore biological function.
4
Q
Classification of Medical Devices
A
4 Classes
I lowest risk
IV Highest Risk
5
Q
Class I
A
Minimal risk of harm to patient.
6
Q
Class II
A
- Penetrate the body through an orifice
- In contact with surface of the eye
- non-invasive device that comes in contact with injured skin.
7
Q
Class III
A
- Invasive device to be absorbed by the body
- Invasive device intended to remain in the body for at least 30 consecutive days
- Introduce fluids, emissions to the body for the purpose of therapy and treatment.
8
Q
Class IV
A
Surgically invasive device intended to diagnose, monitor, control, correct defect of:
1. Central Cardiovascular system
2. Central nervous system
3. Fetuse in-utero
9
Q
Manufacturer’s Obligations
A
- Make sure medical devices meets safety and effectiveness requirements
- Objective evidence to establish that the medical device meets those requirements
10
Q
Safety & Effectiveness Requirements
A
- Eliminate or minimize risks
- Provide Protection and inform user of risk
- Shall notaffect the health or safety of patient (except when benefit outweigh risks)
- Characteristics should not deteriorate under normal use or transport or storage
