Test 2 Clinical Regulations Issues

Question 1

Medical Device

Answer 1

something that is used for the intention of diagnosis, mitigation, treatment, or prevention of disease

Question 2

Drug

Answer 2

primary intended use achieved through chemical action or metabolism

Question 3

Biological Products

Answer 3

a virus, toxin, antitoxin, vaccine, blood, or blood component, applicable to the prevention, treatment, or cure of a disease or condition of somone

Question 4

combination product

Answer 4

comprised of two or more regulated components

drug/device biologic/device drug/device/biologic

Question 5

Class 1 device classification

Answer 5

low to moderate risk, general controls, not to present a potential and unreasonable risk of illness or injury 510(k) submission

Question 6

Class 2 device Classification

Answer 6

moderate to high risk, general and special controls, special labeling, human clinical trials may be needed, post market surveillance, 510(k)

Question 7

Class 3 device Classification

Answer 7

high risk, sustains life, implanted, presents a potential for unreasonable risk of illness or injury, subject to general and special controls, premarket approval (PMA)

Question 8

General Controls

Answer 8

Must,
register manufacturing locations with FDA,
list all marketed medical devices with FDA
manufacture devices in compliance with FDA (QSRs)
label devices in compliance with applicable regulations
submit premarket notification 510(k)

Question 9

Special Controls

Answer 9

Special labeling requirements
conformance with FDA guidance documents
mandatory performance standards
clinical trials
post market surveillance

Question 10

510(k)

Answer 10

“predicate device”, must provide substantial evidence to predicate devices, performs same function, intended uses are comparable, any differences do not raise safety or efficacy concerns
average 93 day clearance

Question 11

(PMA)

Answer 11

Scientific review of safety and efficacy
involves FDA and
average 250 days for approval
license granted to market the device
involves clinical studies

Question 12

Humanitarian Device Exemption

Answer 12

expedited pathway to market, patients with a disease or or condition that affects fewer than 8000 people per year, financial incentive for manufacturers to develop devices

Question 13

Breakthrough Device Designation

Answer 13

Intended to treat or diagnose life threatening diseases or conditions, breakthrough technology that provides advantage over existing technologies no approved treatment or means of diagnosis exists

Question 14

De Novo Classification

Answer 14

have not been classified and are automatically classified as class three, if no predicates then 510(k) not an option, manufacturers can request lower classifications

Question 15

Clearance

Answer 15

going through 510(k) device is cleared, medical devices are cleared by the FDA

Question 16

Approval

Answer 16

going through PMA process devices are approved, drugs are approved by the FDA, most devices aren’t approved, only cleared

Question 17

Class 1 recall

Answer 17

Based on risk, strong likelihood product will seriously affect health or cause death

Question 18

Class 2 recall

Answer 18

may cause temporary or reversible health problems

Question 19

Class 3 recall

Answer 19

not likely to cause serious adverse health problems

Question 20

response actions to recalls

Answer 20

repair or retrofitting, letters of instructions to users, software updates, shipments of new parts, removal of product from field

Question 21

Cause of recalls

Answer 21

defective devices, unexpected problems that didn’t come up in testing, off label use of product, when it poses a health risk

Question 22

off label use

Answer 22

when a device or drug is used in a way that wasn’t originally intended, eg rogaine / minoxidil

Question 23

MDR

Answer 23

medical device reporting,

User facilities must report a suspected medical device-related death to both the FDA

Question 24

Bench Testing

Answer 24

Tests per industry standards, simulates use in lab setting, environmental testing, minimum number of cycles or hours until failure for expected service life

Question 25

Animal Testing

Answer 25

Required prior to clinical testing, used to test device in similar bodily conditions to humans, eg pigs have a similar urinary tract to humans

Question 26

Human clinical testing

Answer 26

controlled environment and subjects, requires IRB approval, and free and informed consent from the subjects, cant duplicate physiological environment in lab and animal models are not identical to humans

Question 27

free and informed consent

Answer 27

subject knows what they are getting into and agrees without any sort of coercion

Question 28

Package testing

Answer 28

Simulates distribution, conducted on final product simulates environmental conditions and distribution history

Question 29

Shelf life testing

Answer 29

Determine how long product can sit on shelf with no change in physical properties or performance, real time and accelerated aging studies

Question 30

Design and development planning

Answer 30

plan to design and develop product, including schedule, required resources, and responsibilities

Question 31

Design Input

Answer 31

customer needs, regulatory requirements, applicable standards, initial design characteristics

Question 32

Design output

Answer 32

Product and process documentation to create prototype or product, reports show that design meets design input requirements

Question 33

Design Reviews

Answer 33

Formal and documented procedure for assessing design results, identify problems / defects, unbiased review by independent reviewers

Question 34

Design verification and Validation

Answer 34

Verification : did we make the RIGHT product?
(confirm that product meets performance specifications)

Validation : did we make the PRODUCT right?
(confirm that product meets customer needs)

Question 35

Design Transfer (Translation)

Answer 35

Design results are translated into product specifications to allow manufacturing to produce,
transfer everything
drawings, work instructions, test results, Bills of material

Question 36

Risk calculation

Answer 36

(probability of occurrence) x (severity)
(test data / field complaints) x ( subjective estimate)

Question 37

Risk mitigation

Answer 37

label warnings, instruction manuals, send someone to explain the proper use of product