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BIM Final Review 2
Lecture 2: Medical Devices
| Question | Answer |
|---|---|
| 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 |
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