Test 2 Clinical Regulations Issues Flashcards
Medical Device
something that is used for the intention of diagnosis, mitigation, treatment, or prevention of disease
Drug
primary intended use achieved through chemical action or metabolism
Biological Products
a virus, toxin, antitoxin, vaccine, blood, or blood component, applicable to the prevention, treatment, or cure of a disease or condition of somone
combination product
comprised of two or more regulated components
drug/device biologic/device drug/device/biologic
Class 1 device classification
low to moderate risk, general controls, not to present a potential and unreasonable risk of illness or injury 510(k) submission
Class 2 device Classification
moderate to high risk, general and special controls, special labeling, human clinical trials may be needed, post market surveillance, 510(k)
Class 3 device Classification
high risk, sustains life, implanted, presents a potential for unreasonable risk of illness or injury, subject to general and special controls, premarket approval (PMA)
General Controls
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)
Special Controls
Special labeling requirements
conformance with FDA guidance documents
mandatory performance standards
clinical trials
post market surveillance
510(k)
“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
(PMA)
Scientific review of safety and efficacy
involves FDA and
average 250 days for approval
license granted to market the device
involves clinical studies
Humanitarian Device Exemption
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
Breakthrough Device Designation
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
De Novo Classification
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
Clearance
going through 510(k) device is cleared, medical devices are cleared by the FDA
Approval
going through PMA process devices are approved, drugs are approved by the FDA, most devices aren’t approved, only cleared
Class 1 recall
Based on risk, strong likelihood product will seriously affect health or cause death
Class 2 recall
may cause temporary or reversible health problems
Class 3 recall
not likely to cause serious adverse health problems
response actions to recalls
repair or retrofitting, letters of instructions to users, software updates, shipments of new parts, removal of product from field
Cause of recalls
defective devices, unexpected problems that didn’t come up in testing, off label use of product, when it poses a health risk
off label use
when a device or drug is used in a way that wasn’t originally intended, eg rogaine / minoxidil
MDR
medical device reporting,
User facilities must report a suspected medical device-related death to both the FDA
Bench Testing
Tests per industry standards, simulates use in lab setting, environmental testing, minimum number of cycles or hours until failure for expected service life
Animal Testing
Required prior to clinical testing, used to test device in similar bodily conditions to humans, eg pigs have a similar urinary tract to humans
Human clinical testing
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
free and informed consent
subject knows what they are getting into and agrees without any sort of coercion
Package testing
Simulates distribution, conducted on final product simulates environmental conditions and distribution history
Shelf life testing
Determine how long product can sit on shelf with no change in physical properties or performance, real time and accelerated aging studies
Design and development planning
plan to design and develop product, including schedule, required resources, and responsibilities
Design Input
customer needs, regulatory requirements, applicable standards, initial design characteristics
Design output
Product and process documentation to create prototype or product, reports show that design meets design input requirements
Design Reviews
Formal and documented procedure for assessing design results, identify problems / defects, unbiased review by independent reviewers
Design verification and Validation
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)
Design Transfer (Translation)
Design results are translated into product specifications to allow manufacturing to produce,
transfer everything
drawings, work instructions, test results, Bills of material
Risk calculation
(probability of occurrence) x (severity)
(test data / field complaints) x ( subjective estimate)
Risk mitigation
label warnings, instruction manuals, send someone to explain the proper use of product
