Device Development Process Flashcards
Devices for which general controls alone are insufficient to assure safety and effectiveness, and existing methods are available to provide such assurances, fall into which regulatory class?
Class II
Which device development class does this describe?
Highest risk; PMA usually required, clinical trials absolutely necessary
Class III
Which device development class does this describe?
Moderate risk, usually requires 510(k),
might require PMA; Generally requires some clinical data
Class II
In addition to complying with general
controls, ____ devices are also subject to
Special Controls.
Class II
Devices for which insufficient information exists to assure safety and effectiveness solely through general or special controls fall into which regulatory class?
Class III
Medical devices such as powered wheelchairs, infusion pumps,
and surgical drapes are examples of which regulatory class?
Class II
General controls alone are sufficient to
provide reasonable assurance of the safety and effectiveness of the device in which regulatory class?
Class I
Medical devices such as elastic bandages, examination gloves, and hand-held surgical instruments are examples of which regulatory class?
Class I
Medical devices such as replacement heart valves, silicone gel-filled breast implants, implanted cerebella stimulators, and implantable pacemaker pulse generators are examples of which regulatory class?
Class III
Devices which are usually those that support or sustain human life and are of substantial importance in preventing
impairment of human health, or present a
potential, unreasonable risk of illness or
injury fall into which regulatory class?
Class III
Which device development class does this describe?
Lowest risk, clinical trials generally not required
Class I
