Food and Drug Administration

Predicate Device

A legally marketed device

Combination Device

A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity Typically Class III Devices

Investigational Device Exemption (IDE)

Allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data

Medical Device

An instrument, apparatus, implant, in vitro reagent, or similar or related article that is used to diagnose, prevent, or treat disease or other conditions, and does not achieve its purposes through chemical action within or on the body

Food and Drug Administration (FDA)

Assures safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the US food supply, cosmetics, and products that emit radiation Advance public health by speeding innovations that make medicines and food safer, more effective, and more affordable Provides public with accurate science-based info to aid in the use of medicines and foods to improve health

Substantial Equivalence

At least as safe and effective as a legally marketed device that is not subject to PMA

Premarket Notification: 510(k)

Device must be proven to be substantially equivalent to a device that was legally marketed before the Medical Device Amendments were passed (1976) Must still perform post-market surveillance FDA clearance rather than FDA approval

Direct Contact Test

Device specimen placed directly onto confluent cell monolayer; cells are fixed and stained, with dead cells losing adherence during fixation Advantages: zone of diffusion, cell contact, mimic in vitro conditions Disadvantages: cellular trauma with high density material or material movement

Elution Test

Device specimen submerged in solutions to create extracts of varying concentrations, extracts are plated on near confluent cell monolayer Advantages: dose response effect, choice of extract condition and solvents, separate extraction from testing Disadvantages: additional time and steps

Agar Diffusion Test

Device specimens are placed on a confluent cell monolayer submerged in agar; stain is taken up by healthy cells, with dead or damaged cells remaining colorless Advantages: zone of diffusion, concentration gradient, test one side of material, independent of material density Disadvantages: flat surface required, toxicant may not be soluble in agar, limited exposure time

Cytotoxicity

Causing toxic effects at the cellular level

American Type Culture Collection (ATCC)

Collects, stores, and distributes standard reference microorganisms, cell lines and other materials for research and development

American Society for Testing Materials International (ASTM)

International standards organization that develops and publishes voluntary consensus technical standards for a wide range of materials, products, systems, and services Founded to serve railroad industry

Premarket Approval

FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices

Class III Device

General Controls and Premarket Approval (PMA) Device that is life-sustaining, life-supporting, or substantially important in preventing impairment of health; device presents a potential unreasonable risk of illness or injury; device failure causes life-threatening injury Submission Type: 510(k) or PMA ~10% of medical devices Ex: implantable pacemakers, breast implants

Class II Device

General Controls with Special Controls: specialized labeling, post-market surveillance Typically noninvasive devices, no clinical trials required Submission Type: 510(k) (Premarket Notification) ~43% of medical devices Ex: x-ray machine, powered wheelchair, infusion pump, many orthopedic devices, pregnancy test

Class I Device

General Controls; minimal potential for harm to the user Subject only to general controls: registration of company with FDA, GMPs, proper labeling, general reporting Submission Type: 510(k) Exempt Ex: dental floss, toothbrush, tongue depressor, gloves, tweezers

Center for Devices and Radiological Health (CDRH)

Regulates firms who manufacture, relable, and or important medical devices sold in the US

Institutional Review Board (IRB)

Regulates human trials and clinical research

Federal Food, Drug, and Cosmetic Act of 1938

Response to sulfilidamide disaster; required safety testing; Birth of FDA

International Organization for Standardizations (ISO)

World's largest developer and publisher of international standards; nongovernmental organization; voluntary participation;performs audits

Medical Device Amendments of 1976

Distinguished between drugs and medical devices, classified devices, and established regulations for good manufacturing practices (GMPs) Required that reasonable assurance of safety and effectiveness be provided for all devices

Institutional Animal Care and Use Committee (IACUC)

reviews research animal testing protocols and conducts evaluations of animal care