Medical Devices and FDA

what does ASTM stand for

american society of testing and materials

control of class 3 devices

pre-market approval (PMA)

scaffold seeded with autologous cells

CBER

Drug-eluting disc (oncology)

CDER

chemo drug/monoclonal antibody

CDER

contact lens/glaucoma drug

CDER

interferon/Ribivarin therapy

CDER

Drug-eluting stent

CDRH

embolization implant device/chemo drug

CDRH

spinal fusion device/therapeutic protein

CDRH

vertebroplasty device/analgesic

CDRH

What is CBER

Center for Biological Evaluation Research

What does FDA stand for?

Food and Drug Administration

what does IRB stand for

Institutional Review Board

What does MDR stand for?

Medical Device Reporting

What happened in 1990?

Safe Medical Device Act (SMDA)

What's the big challenge when selecting animals?

animal brains/neuro are different than humans

informed consent

legal condition in which an individual has given consent based on understanding the facts and potential implication of an action; must be in the right mind to give consent; legal guardian, parent, or care-giver can step in if needed

substantial equivalence

-device has same intended use and tech characteristics as predicate OR -device has same intended use but diff tech char. than predicate

What new amendments were added to FD&C?

-extended FDA control over food and drugs -ensured proper labeling and removed fraudulent devices from market -authorized factory inspections -required new drugs to be proven safe prior to marketing

What was the main point of the medical device amendments?

-gave FDA the authority to regulate devices during development, testing, production, distribution, and use

What was included in the SMDA?

-less than 1% of hospitals reported device malfunction -FDA requires facilities to report any incidence of device malfunction leading to death, serious injury, or illness (MDR) -post market surveillance required by device manufacturers -provided the FDA with the power to recall

Class 3

-life sustaining

Control of class 1 devices

-manufacturer register with FDA -good manufacturing practices -proper branding and labeling -maintain records

smaller points of medical device amendments

-manufacturers had to register with FDA and follow quality control procedures -some products needed to have a premarket approval by FDA -others must meet performance standards -provided for 3 classes of medical devices

Class 1

-minimal potential for harm, simple design

Class 2

-non invasive, medium risk -FDA 510 k approval -must meet performance standards for predicate if applicable

what does GMP require

-personnel certification and expertise -lab notebooks of experiments -instrument calibration and operation -plant assessment -quality control -processes/procedures for self-assessment -required by law or something

510 k is required when

-proposed different use than predicate -significantly modified predicate

What does the FDA do?

-regulation of medical devices/diagnostic products ensuring treatment efficacy and patient safety -work hand-in-hand with medical device companies -provide public health notifications and recalls -work to promote technology advancement

non-clinical studies

1. engineering tests (wear, fatigue, compression) 2. abiotic/in vitro toxicity (cell culture models)

pre-clinical studies

1. non-functional test (biocompatibility) 2. functional model (device has to function in an injury model

Class 3 is ______ % of medical devices

10

What happened in 1906?

1st Food, Drug, and Cosmetic Act (FD&C)

How many clinical trial phases are there?

3

When FDA decision is made, people have _________ to petition for reconsideration

30 days

Class 2 is ______ % of medical devices

43

Class 1 devices are ______ % of all medical devices

47

If a class 3 device fails to meet PMA requirements, it is considered adulterated under section ___________ of the ________ and can't be marketed

501 f, FD&C Act

For 510 k, manufacturer must submit at least ________ prior to marketing device and has to have FDA clearance

90 days

Who decides on the classification of a device as well as approval/disapproval?

Advisory committee makes recommendations to the FDA based on user, conditions of use, benefit to risk, device reliability FDA has final say

What is CDRH

Center for Devices and Radiological Health

What is CDER

Center for Drug Evaluation Research

Premarket approval (PMA)

FDA process of scientific and regulatory review to evaluate the safety and effectiveness of class 3 medical devices -most stringent type of device marketing

What happened in 1976?

Medical device amendments

510 k

a premarket submission to FDA describing data that proves safety and effectiveness of device

refinement

alleviate pain, suffering, distress; maintain facilities and programs

Who is subject to the approval process?

anyone who wants to market a medical device for human use

What is IDE

begin using in controlled studies to gather needed evidence for further approval; ASTM and ISO work together

What does CBER do

biologics (newer components), blood and byproducts, cell and gene therapy products

Medical device regulation is based on

class type

multi-center

conducted at multiple clinic or medical centers, more diverse patient demographics, results more applicable to general public

ideal animal model

consistent w/human anatomy, reproducible, cost effectiveness, life expectancy with human aging

ASTM F561-05A

covers recommendations for retrieval, handling, and analysis of implanted devices

Clinical trial phase 1

determine dosing, side effects, safety; up to 1 month; small sample size (20-40); healthy volunteers; one center/hospital

What is a medical device

doesn't achieve primary intended purposes through chemical action and which isn't dependent upon being metabolized -distinction from a drug, more of a structural effect

randomized

each subject randomly assigned to receive treatment or placebo

What does the IRB do

ensures the rights and welfare of human research subjects are good; power to approve, monitor, etc biomed and behavioral research involving humans; at least 5 people with experience on board

why do manufacturers retrieve devices

examine integrity, functionality and human biocompatibility

Market approval for class 1/time

exempt from preapproval, little paper work

What happened in 1938?

federal FD&C passed with new amendments

what is GMP

general set of rules that provide guidelines for producing devices in the best way possible - covers design and manufacturing

what does GMP stand for

good manufacturing practices

what does IACUC do

group of researchers/vets that oversee animal research

What does MDR do

have to report adverse events (post market surveillance) and manufacturers must call FDA ASAP after incident has been reported; need to report a death/serious illness within 10 days to FDA and manufacturer

clinical studies

human studies, device failures and replacements, etc

Class 2 examples

imaging tech, sutures, needles, wheel chairs

class 3 examples

implantable pacemakers, breast implants

Clinical trial phase 2

increase patient number (100-200); safety is primary endpoint; signs of efficacy; several months; looking for something encouraging; could be more than one center

what does IACUC stand for

institutional animal care and use committee

Classification depends on

intended use and indications for use and risk involved with function/failure

what does iso stand for

international standards organization

what does IDE stand for

investigational device exemption

how can substantial equivalence be proved

limited testing, literature review, references

2 things of animal model selection

literature review and ideal animal model

Function compatibility test

material placed in anatomical location in which it would normally experience in-service life; tissue in growth, wear debris; expensive; requires design of animal version

Unfunctional compatibility test

material places in anatomic location not of intended, focused on direct interactions between the substance of the material and the chemical/biological species of implant environment

medical devices can be made from

metals, polymers, or ceramics

3 types of PMA

non-clinical studies, pre-clinical studies, clinical studies

Office of Combination Products

oversees products that constitute a combination of a device, drug, and/or biologic assigns one center for primary review and oversees approval process

Off label use

permitted at doctor's discretion, may not be marketed by manufacturer used for something other than intended use

market approval for class 3/time

premarket approval (PMA), 10 years

market approval for class 2/time

premarket notification (510 k), 12-18 months

What is the FD&C?

prohibited interstate commerce of misbranded and adulterated food, drinks, and drugs

Types of informed consent

purpose statement of research, description of procedure, possible side effects, etc, authorization for release of medical info

Responsible use of animals (3 R's)

replacement, reduction, refinement

double-blind

researches and subject don't know which study treatment was received

Clinical trial phase 3

safety; real focus (efficacy-why we need a large sample size); large patient number (1000+); several years

Control of class 2 devices

special labeling, mandatory performance standards, post-market surveillance

literature review

specifics of the system, physiological and chemical nature of the system, applicable to humans

Class 1 examples

tongue depressor, dental crowns, bandaid, gloves, toothbrush

what does CDER do

traditional "drugs" (pharmaceuticals)

What does CDRH do?

traditional devices

replacement

use abiotic or invitro models whenever possible

reduction

use minimal sample size, prevent duplication of research