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, MR’s 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 operatingcost, 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 Administration’s (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(FD&C Act or “the Act”) are regulated by the Food and DrugAdministration (FDA). Medical devices are subject to general controls and othercontrols in the FD&C Act. General controls of the FD&C 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 FD&C 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 FD&C 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 because they areaccessories to finished devices and meet the above definition of a device. Software that is to be marketed to enhance the performance of a device isregulated as an accessory to that device. Software that enhances the performanceof a group of different devices is regulated as an accessory to the device thatposes the greatest risk to the patient. The manufacturer of accessories issubject to the medical device regulations when the accessory is labeled andmarketed separately from the primary device for a health-related purpose to ahospital, 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 inthe U.
S. must submit a 510(k) (premarket notification) to FDA at least 90 daysbefore 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 bemarketed is as safe and effective, that is, substantially equivalent, to alegally marketed device that is not subject to premarket approval. Premarketapproval (PMA) is the most stringent type of device marketing applicationrequired by FDA.
A PMA is an application submitted to FDA to request clearanceto market, or to continue marketing the medical device. Unlike premarketnotification, PMA approval is to be based on a determination by FDA that the PMAcontains sufficient valid scientific evidence that provides reasonable assurancethat the device is safe and effective for its intended use or uses. In the firststage of the design process, the Product team, with the assistance of theRegulatory Affairs team, determines the regulatory requirements for a product. One of the key requirements that must be considered is if a 510(k) submission isrequired in order to distribute the product in the United States. The productteam leader completes a Regulatory Impact Assessment (RIA) to determine if sucha submission is needed. After completing the product information required by theRIA, the Product Team Leader submits the information to the Regulatory Affairssection to determine whether the new product requires a 510(k).
If Regulatorydetermines that a 510(k) submission is needed for one or more features includedin the product, the Product Team Leader should incorporate the submissionstrategy into the design plan for the product. The strategy should include boththe number of submissions required for the product (individual features may besubmitted separately) and the type of submission to be filed for each feature. Based on the type of feature/product and the needs of the business, theRegulatory group may recommend one of the four types of 510(k) submissions. ? Special 510(k): This type of a submission can be used in cases wherethere is no change in the intended use of the device or in the fundamentalscientific technology of the device. Instead of submitting data to support thesubmission, the manufacturer submits a “Declaration of Conformity”with the design control requirements in the Quality System Regulations and abrief summary of their design control process. All design control activities andverification/validation tests specified in the Risk Analysis must be completedat the time of the submission.
The advantage of this type of submission is thatFDA will make a clearance decision in 30 days. ? Abbreviated 510(k): Thistype of a submission can be used in cases where there is a device-specificguidance document or FDA has recognized a relevant consensus standard. Insteadof submitting data to support the submission, the manufacturer submits a”Declaration of Conformity” to the recognized standard and a briefsummary of the activities taken to meet that standard. All activities requiredby the recognized standard must be completed at the time of the submission FDAdoes not guarantee a shorter review time with this type of submission, but theybelieve review times should be shorter. ? Traditional 510(k): This typeof a submission can be used in all cases These submissions can containpromissory notes on activities that will be done prior to commercialdistribution, but have not necessarily been completed at the time of thesubmission.
FDA is supposed to give a clearance decision for the submission in90 days. Note: if they formally request (i. e. in writing) additionalinformation, the review time clock starts over at zero once that information issubmitted. ? Third-Party Reviewed 510(k) ? These submissions aresimilar to traditional 510(k) submissions. However, the initial review isconducted by a qualified third party at a predetermined expense.
Once the thirdparty completes the review, the submission is forwarded to FDA for final reviewand clearance. Although there is a cost involved with this submission, thereview time is typically shorter (30-45 days) since they bypass the queue ofsubmissions at FDA. The Regulatory Affairs Group prepares and submits alldocumentation required for FDA approval/clearance of new products andmodifications/ upgrades to existing products. The team is responsible for allinteractions with government regulatory agencies and Industry Relations(Corporate) Department.
It also monitors and follows-up Medical Device Reporting(MDR) requirements and monitors compliance with the Safe Medical Devices Act andother medical device legislation. When a manufacturer decides to modify anexisting device, they must decide whether the proposed device modificationrequires submission of a 510(k). It is not FDA’s intent that a 510(k) must besubmitted for every modification. However, all changes in indications for userequire the submission of a 510(k). Examples of modifications that may require a510(k) submission include the following: ? Sterilization method ?Structural material ? Manufacturing method ? Operating parametersor conditions for use ? Patient or user safety features ? Sterilebarrier packaging material ? Stability or expiration claims ?Design FDA believes that the manufacturer is best qualified to determine whenmodifications to their device could significantly affect safety oreffectiveness.
Therefore, every modification to the device should be reviewed byappropriate personnel to determine if it affects safety or efficacy. If it isdetermined that the modification is not significant, the basis for this decisionshould be documented with supporting data in the manufacturer’s device masterfile. If it is determined that the modification is significant, then a complete510(k) must be submitted to FDA. If FDA finds the device to be substantiallyequivalent, FDA will send the manufacturer a marketing clearance letter,referred to as an “SE letter”, and the device may be marketed asdescribed in the 510(k). If FDA finds the device not to be substantiallyequivalent, FDA will send a not-substantially equivalent letter. In the latterinstance, the manufacturer may chose to resubmit another 510(k) with newinformation, may petition FDA requesting the device be reclassified or maysubmit a PMA.
Manufacturers may not place their device into U. S. commerce untilthey receive a marketing clearance letter from FDA. Once they receive theapproval letter, they can then sell the product to the U.
S. market. In addition,before clearance is obtained the manufacturer must assure that the device isproperly labeled in accordance with FDA’s labeling regulations. Once clearancefor marketing is obtained, the manufacturer must register their establishmentand list the type of device they plan to market with the FDA.
Finally, once onthe market, there are postmarket surveillance controls that a manufacturer mustcomply with; these include the Quality Systems and Medical Device Reporting (MDR)regulations. The QS regulation is a quality assurance requirement that coversthe design, packaging, labeling and manufacturing of a medical device. The MDRregulation provides a mechanism for FDA and manufacturers to identify andmonitor significant adverse events involving medical devices. The goals of theregulation are to detect and correct problems in a timely manner. Although therequirements of the regulation can be enforced through legal sanctionsauthorized by the Federal Food Drug and Cosmetic Act, FDA relies on the goodwilland cooperation of all affected groups to accomplish the objectives of theregulation. Analysis The medical device industry tends to comply with allgovernment regulations to get the product to market.
The more time it takes toget the product to market, the less money the business makes. Many laws tend tobe vague and are subject to interpretation. The problem for medical devicemanufacturers is that many of the laws are broad and written for drugs and notfor medical devices. As a consumer, the FDA is an excellent regulatory body tohave around. For an industry however, it can be very difficult to get throughall the red tape. Entire regulatory departments are needed just so the necessarypaperwork can be generated for market approval.
The FDA does recognize thatthrough constant modification to the existing laws, and assisting the medicaldevice industry in obtaining market approvals, together industry and governmentcan work together to improve healthcare for the general public. Bibliography1. Marconi Medical Systems, Inc. MR GBC Work Instruction MR 313. 2. DuanePraschan, former Regulatory Affairs manager, Marconi Medical Systems.