Quiz 2 (7-9)

Question 1

Goal of needs selection

Answer 1

given a vast list of needs, identify a smaller subset of needs that warrants further investigation

Question 2

6 steps for needs selection

Answer 2

1. Select factors
2. Assign ratings for each factor
3. Score and rank the needs
4. select smaller set of needs
5. perform research and then repeat
6. engage key stakeholders when list is small enough

Question 3

Need specifications

Answer 3

detailed but stand alone doc that presents need statement and summarizes data gathered

Question 4

HMW technique

Answer 4

convert needs statement into questions using the format “How might we…?

Question 5

When were devices first subject to pre-market review?

Answer 5

after Medical Device amendments act of 1976

Question 6

What is the FDA’s goal?

Answer 6

protect public health by assuring safety and effectiveness

Question 7

What does the FDA not regulate?

Answer 7

price/reimbursement amt, cost effectiveness, physician malpractice

Question 8

Class 1 Devices

Answer 8

ex. bandages, gloves
mostly exempt from premarket clearance, no trials, but have to register with FDA

Question 9

Class 2 Devices

Answer 9

ex. x-ray machines, surgical needles
use 510(k) approval process

Question 10

Class 3 Devices

Answer 10

ex. heart valves, implantable devices
use PMA regulatory pathways and has stringent regulatory requirements

Question 11

510(k) pathway

Answer 11

largest category of medical device applications

Question 12

De Novo 510(k) pathway

Answer 12

intended for devices that do not have major risks of Class 3 but for which no predicates exist

Question 13

Pre market approval (PMA) pathway

Answer 13

most stringent pathway, used for devices that are significantly different and/or represent highest risk