Medical Devices FDA Magnetic Resonance division designs, manufactures, and installs MRI systems and associated equipment for the worldwide medical diagnostic imaging market. In addition, Marconi MR imports MRI systems from Nordstar (located in Helsinki, Finland) and installs them in the United States. Associated equipment includes surface coils and physician viewing stations. Surface coils are specialized transducers, which, when used with an MRI machine, produce high-quality images of specific portions of the anatomy. MR designs, manufactures, and installs surface coils as well.
Marconi Medical Systems as a whole, is a transnational corporation. While retaining its strength in the United Stated, MRs products have achieved global recognition. Strengths in markets such as Europe and South America have opened doors to Asian countries such as Japan and China. MR has a variety of customers, but focuses primarily on hospitals and imaging centers. MR customers expect high quality systems that are easy to use, have low operating cost, high throughput, and can support new technology.
An MR system must provide superior image quality and offer a range of imaging techniques to support diagnosis. Given the high cost of the equipment ($900,000 on average), customers expect smoothly installed, easy to operate, reliable, low maintenance equipment that provides a solid return on investment. To make all this possible, Marconi must pass the Food and Drug Administrations (FDA) stringent policies and procedures for the safe and effective use of a medical device. Advantages of MRI Unlike x-ray based medical diagnostic techniques such as computed tomography, magnetic resonance imaging (MRI) and spectroscopy are techniques that do not employ ionizing radiation. As such, it is considered to be less hazardous than other x-ray imaging techniques.
In addition, since x-rays can only discriminate different tissues by electron density, which does not vary greatly between soft tissues, the injection of contrast media is often necessary. In MRI, however, there are a number of tissue specific parameters which can affect magnetic resonance (MR) signals. One of the most important advantages of MRI is its capacity for displaying soft tissue contrast. An example of this capacity is the discrimination between the gray and white matter of the brain that can be accomplished with MRI. Image contrast can be tailored to the specific clinical application so that specific types of pathology are emphasized. In addition, since MRI is unobstructed by bone, it is especially beneficial in imaging of the brain and spinal cord.
MRI also has the unique ability to acquire images in numerous planes without repositioning the patient. Three-dimensional recreations of anatomic structure can be obtained. These characteristics render MRI a very effective and important tool for soft tissue imaging. Regulations Products meeting the definition of a device under the Federal Food, Drug and Cosmetic Act (FD&C Act or “the Act”) are regulated by the Food and Drug Administration (FDA). Medical devices are subject to general controls and other controls in the FD&C Act. General controls of the FD&C Act are the baseline requirements that apply to all medical device manufacturers. Unless specifically exempted, medical devices must be properly labeled and packaged, be cleared for marketing by the FDA, meet their labeling claims, and be manufactured under Good Manufacturing Practices (GMP), which is a mandated quality assurance system.
FDA regulates devices to assure their safety and effectiveness. To fulfill provisions of the FD&C Act, FDA develops rules to regulate devices intended for human use. These rules regulate various aspects of the design, clinical evaluation, manufacturing, packaging, labeling, commercial distribution, and postmarket surveillance of devices. These regulations are published in the Federal Register. Final regulations are codified annually in the Code of Federal Regulations (CFR).
What is a Medical Device? The definition of a device appears in section 201(h) of the FD&C Act. A device is: “..an instrument, apparatus, implement, machine, contrivance, implant, in vitro 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, ? intended for 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 or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes..” Accessories and Components Certain components such as blood tubing sets, major diagnostic x-ray components, and stand-alone software are regulated by the FDA as finished devices because they are accessories to finished devices and meet the above definition of a device. Software that is to be marketed to enhance the performance of a device is regulated as an accessory to that device. Software that enhances the performance of a group of different devices is regulated as an accessory to the device that poses the greatest risk to the patient. The manufacturer of accessories is subject to the medical device regulations when the accessory is labeled and marketed separately from the primary device for a health-related purpose to a hospital, physician, or other end user.
So, you want to sell a medical device? Each manufacturer who wants to market medical device intended for human use in the U.S. must submit a 510(k) (premarket notification) to FDA at least 90 days before marketing unless the device is exempt from 510(k) requirements. A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to premarket approval. Premarket approval (PMA) is the most stringent type of device marketing application required by FDA. A PMA is an application submitted to FDA to request clearance to market, or to continue marketing the medical device.
Unlike premarket notification, PMA approval is to be based on a determination by FDA that the PMA contains sufficient valid scientific evidence that provides reasonable assurance that the device is safe and effective for its intended use or uses. In the first stage of the design process, the Product team, with the assistance of the Regulatory Affairs team, determines the regulatory requirements for a product. One of the key requirements that must be considered is if a 510(k) submission is required in order to distribute the product in the United States. The product team leader completes a Regulatory Impact Assessment (RIA) to determine if such a submission is needed. After completing the product information required by the RIA, the Product Team Leader submits the information to the Regulatory Affairs section to determine whether the new product requires a 510(k). If Regulatory determines that a 510(k) submission is need …