Medical Devices FDA Essay Example For Students

Medical Devices FDA Essay Magnetic Resonance division designs, manufactures, and installs MRI systems andassociated equipment for the worldwide medical diagnostic imaging market. Inaddition, Marconi MR imports MRI systems from Nordstar (located in Helsinki,Finland) and installs them in the United States. Associated equipment includessurface coils and physician viewing stations. Surface coils are specializedtransducers, which, when used with an MRI machine, produce high-quality imagesof specific portions of the anatomy. MR designs, manufactures, and installssurface coils as well. Marconi Medical Systems as a whole, is a transnationalcorporation. While retaining its strength in the United Stated, MRs productshave achieved global recognition. Strengths in markets such as Europe and SouthAmerica have opened doors to Asian countries such as Japan and China. MR has avariety of customers, but focuses primarily on hospitals and imaging centers. MRcustomers expect high quality systems that are easy to use, have low op eratingcost, high throughput, and can support new technology. An MR system must providesuperior image quality and offer a range of imaging techniques to supportdiagnosis. Given the high cost of the equipment ($900,000 on average), customersexpect smoothly installed, easy to operate, reliable, low maintenance equipmentthat provides a solid return on investment. To make all this possible, Marconimust pass the Food and Drug Administrations (FDA) stringent policies andprocedures for the safe and effective use of a medical device. Advantages of MRIUnlike x-ray based medical diagnostic techniques such as computed tomography,magnetic resonance imaging (MRI) and spectroscopy are techniques that do notemploy ionizing radiation. As such, it is considered to be less hazardous thanother x-ray imaging techniques. In addition, since x-rays can only discriminatedifferent tissues by electron density, which does not vary greatly between softtissues, the injection of contrast media is often necessary . In MRI, however,there are a number of tissue specific parameters which can affect magneticresonance (MR) signals. One of the most important advantages of MRI is itscapacity for displaying soft tissue contrast. An example of this capacity is thediscrimination between the gray and white matter of the brain that can beaccomplished with MRI. Image contrast can be tailored to the specific clinicalapplication so that specific types of pathology are emphasized. In addition,since MRI is unobstructed by bone, it is especially beneficial in imaging of thebrain and spinal cord. MRI also has the unique ability to acquire images innumerous planes without repositioning the patient. Three-dimensional recreationsof anatomic structure can be obtained. These characteristics render MRI a veryeffective and important tool for soft tissue imaging. Regulations Productsmeeting the definition of a device under the Federal Food, Drug and Cosmetic Act(FDC Act or the Act) are regulated by the Food and DrugAd ministration (FDA). Medical devices are subject to general controls and othercontrols in the FDC Act. General controls of the FDC Act are thebaseline requirements that apply to all medical device manufacturers. Unlessspecifically exempted, medical devices must be properly labeled and packaged, becleared for marketing by the FDA, meet their labeling claims, and bemanufactured under Good Manufacturing Practices (GMP), which is a mandatedquality assurance system. FDA regulates devices to assure their safety andeffectiveness. To fulfill provisions of the FDC Act, FDA develops rules toregulate devices intended for human use. These rules regulate various aspects ofthe design, clinical evaluation, manufacturing, packaging, labeling, commercialdistribution, and postmarket surveillance of devices. These regulations arepublished in the Federal Register. Final regulations are codified annually inthe Code of Federal Regulations (CFR). What is a Medical Device? The definitionof a device appears in section 201(h) of the FDC Act. A device is:an instrument, apparatus, implement, machine, contrivance, implant, invitro reagent, or other similar or related article, including a component, part,or accessory, which is: ? recognized in the official National Formulary,or the United States Pharmacopeia, or any supplement to them, ? intendedfor use in the diagnosis of disease or other conditions, or in the cure,mitigation, treatment, or prevention of disease, in man or other animals, or? intended to affect the structure or any function of the body of man orother animals, and which does not achieve any of its primary intended purposesthrough chemical action within or on the body of man or other animals and whichis not dependent upon being metabolized for the achievement of any of itsprimary intended purposes Accessories and Components Certain componentssuch as blood tubing sets, major diagnostic x-ray components, and stand-alonesoftware are regulated by the FDA as finished devices becau se they areaccessories to finished devices and meet the above definition of a device. Mexican National Flag And Crest Persuasive EssayBibliography1. Marconi Medical Systems, Inc. MR GBC Work Instruction MR 313. 2. DuanePraschan, former Regulatory Affairs manager, Marconi Medical Systems. 3. http://www.fda.gov/