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Marketing a medical device by John Robinson
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Marketing a medical device |
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Health
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If manufacturing a medical device is one thing; marketing it is an altogether different one. It obviously goes without saying that a manufactured product is useless in itself unless it reaches the market. Marketing a medical device in the US entails having to carry out many steps, all of which need to be properly done and carried out at the appropriate time. What are the steps the FDA expects from a manufacturer of a medical device? Subject to controls Every medical device that is meant for marketing is bound by the general controls of the Federal Food Drug & Cosmetic (FD&C) Act. These controls are located in 21 CFR Parts 800-1299. The aim of these controls is to state the requirements that are necessary for all medical devices. These controls cover aspects relating to labeling, marketing, and performance monitoring after the device enters the market. Marketing approval involves three steps If a medical device has to be marketed; the first course of action is to determine whether the product is a medical device. 201(h) of the FD&C Act states the definition of what a medical device is. This is to make sure that the product developed by a manufacturer is indeed fit to be classified as a medical device. Why this step is necessary is that many medical devices also qualify as other products, such as electronic radiation emitting products. Classifying the device The next step is to classify the medical device. The FDA classifies medical devices into three categories: Class I, Class II and Class III medical devices. At their most basic level, this is how these classes go: Class I consists of medical devices for which there are minimum regulatory controls and for which no approval is necessary. It follows from this definition that Class I medical devices are low-risk medical devices. The most common Class I devices that come to mind are bandages, gloves, etc. Class II medical devices are those that require a slightly high degree of special controls in addition to general controls. Examples of this class are surgical instruments. Class III medical devices require a high degree of FDA premarket notification and post-market surveillance, such as defibrillator for instance. Information about the product The third step is for the manufacturer to gather and present data and/or information necessary for submitting a marketing application, after which the firm has to get FDA clearance to market. Whether submissions are made under 510 (K) or Post Market Approval applications, for most of these; clinical performance data is necessary if the device has to obtain approval for marketing. The manufacturer has to show that the trial was done in accordance with FDA's Investigational Device Exemption (IDE) regulation. Other requirements There are premarket and post market requirements. Premarket requirements includelabeling, registration and listing. Simply put; these stages require these: The manufacturer has to ensure that labeling for the device meetsFDA’s labeling regulations. After this is done; the company has to be registered after clearance for marketing is obtained. At the time of registration, the manufacturer must also mention the type of device it plans to market. This has to be done electronically, unless the manufacturer has been granted a waiver from the FDA. Post market requirements The marketing of a medical device is complete once it meets post market requirements that relate to the product’s Quality System, which relates to Good Manufacturing Practices(GMPs) and Medical Device Reporting, which is essentially about adverse event reporting. GlobalCompliancePanel
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