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BIM Final Review 2

Lecture 2: Medical Devices

FDA Division Center for Drug Evaluation and Research
FDA Division Center for Devices and Radiological Health
FDA Division Center for Biological Evaluation and Research
FDA Division Center for Food Safety and Applied Nutrition
FDA Division Center for Veterinary Medicine
FDA Division Center for Tobacco Products
FDA Division National Center for Toxicologic Research
instrument, apparatus, implement machine, contrivance, implant, in vivo reagent, or other similar or related article, including component part, or accessory Medical device
Medical devices are recognized in what? the official National Formulary, or the US Pharmacopoeia, or any supplement to them
What are medical devices intended to be used for? diagnosis, cure, mitigation, treatment, or prevention
Medical devices are intended to affect the structure of function of the body which does function through chemical action within or on the body which is not depended upon being metabolized
articles intended for the use in the diagnosis, cure, mitigation, treatment, or prevention of disease Intended to affect the structure or function of the body Drug
any drug not generally recognized as safe and effective for use OR which has become so recognized, but which has not been used to a material extent or for a material time New drug
a virus, therapeutic, serum, toxin, vaccine, blood, blood component, blood derivative, allergenic product or analogous product, arsphenamine or derivative product, applicable to the prevent, treatment, or cure of disease or condition Biologic
a single product containing any combination of medical device, drug, or biologic Combination product
Medical device market size $133 billion by 2016
% of global medical device market established in 2012 38%
States with highest # medical device companies CA, FL, NY, PA, MI, MA, IL, MN, GA, WA, WI, TX
>80% of companies have <50 employees Start-ups
Medical device industry subsector Electro-medical pacemakers, MRI machines, etc
Medical device industry subsector Irradiation apparatuses x-ray, CT, etc
Medical device industry subsector Surgical and medical instruments anesthesia apparatuses, orthopedic instruments, etc
Medical device industry subsector Surgical appliances stents, dressings, gloves, etc
Medical device industry subsector Dental equipment cements, chairs, drills, etc
Product development Initiation opportunity and risk analysis phase
Product development Formulation concept and feasibility phase
Product development Design and development verification and validation phase
Product development Final validation product launch prep phase
Last step of Product development Product launch
Created by: 1543931625634163